An interventional study of Feeding study in Obesity, Diabetes and Cardiovascular Disease, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
This study will evaluate the effects of dietary composition on energy expenditure and chronic disease risk factors, while also exploring physiological mechanisms underlying these effects.
Many overweight and obese people can lose weight for a few months, but most have difficulty maintaining weight loss over the long term. One explanation for the poor long-term outcome of weight-loss diets relates to behavior, in that motivation to adhere to restrictive regimens typically diminishes with time. An alternative explanation is that weight loss elicits biological adaptations - specifically a decline in energy expenditure and an increase in hunger - that promote weight regain. The purpose of this study is to evaluate the effects of dietary composition on energy expenditure and risk for chronic diseases, while also exploring physiological mechanisms underlying these effects. The study will be performed in collaboration with Framingham State University, providing a novel and feasible method for feeding subjects in dining halls and monitoring compliance.
Following 12±2% weight loss on a standard run-in diet, 150 adults (aged 18 to 65 years) will be randomly assigned to one of three weight-loss maintenance diets controlled for protein content (20% of energy) and varying widely in dietary carbohydrate-to-fat ratio: Low-carbohydrate (20% of energy from carbohydrate, 60% fat), Moderate- carbohydrate (40% carbohydrate, 40% fat), High-carbohydrate (60% carbohydrate, 20% fat). During the weight-loss maintenance phase, energy intake will be adjusted to prevent changes in body weight. The primary outcome will be change in total energy expenditure (indirect calorimetry using stable isotopes) through 20 weeks. Secondary outcomes during weight maintenance will include resting energy expenditure (indirect calorimetry using respiratory gas exchange), physical activity (accelerometry), measures of insulin resistance and skeletal muscle work efficiency, components of the metabolic syndrome, and hormonal and metabolic measures that might inform an understanding of physiological mechanisms. We also will assess weight change during a 2-week ad libitum feeding phase, as an objective measure of dietary effects on hunger. The analytic framework for addressing study hypothesis will be repeated-measures analysis of variance, with adjustment for covariates (sex, race, ethnicity, age, anthropometrics, insulin sensitivity and secretion, obesity-related genes). We also will test each covariate for effect modification (covariate × diet interaction).
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Exclusion Criteria:
Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
Behavioral: Feeding study
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
Behavioral: Feeding study
Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
Behavioral: Feeding study
Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes
Total energy expenditure (TEE), assessed by indirect calorimetry using stable isotopes Total calories burned: Participants each drank about a cup of water containing special tracers which are measurable when they pass out of the body through urine. They provided a urine sample before they drank the water and then about every other day for the next two (2) weeks. Change: average (midpoint of test phase, end of test phase) - start of trial
Time frame: Start of Trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange
Resting energy expenditure, assessed by indirect calorimetry using respiratory gas exchange Calories burned while resting: Participants lied down with head and neck under a clear plastic "bubble," breathing room air. Gases in expired air were collected. Change: average (midpoint of test phase, end of test phase) - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Physical Activity, Assessed by Accelerometry
Actigraph Accelerometer Change: average (midpoint of test phase, end of test phase) - start of trial An Actigraph Accelerometer measures movement, similar to a pedometer. Data are reported as counts (divided by 1,000) per day. Each participant wore the the accelerometer on the right hip for 7 days at each time point.
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Skeletal Muscle Work Efficiency
Efficiency is expressed as percentage ratio of power generated during cycle ergometry (with conversion of Watts to kcal/min using a factor of 0.01433) to energy expenditure above resting. Change: end of test phase - start of trial.
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Leptin (Start of Trial)
Leptin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 6) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
Time frame: Start of trial (time of randomization, post-weight loss)
Leptin (% Change)
Leptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
Time frame: Change through 20 weeks' weight loss maintenance
Ghrelin (Start of Trial)
Ghrelin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 8) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
Time frame: Start of trial (time of randomization, post-weight loss)
Ghrelin (% Change)
Ghrelin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
Time frame: Change through 20 weeks' weight loss maintenance
1,5-Anhydroglucitol
Biomeasure of carbohydrate intake Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Glycemic Control, Assessed by HgA1c
Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial.
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Triglycerides
Triglyceride levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Body Composition (DXA)
Body fat, presented as a % of total mass Participants each had a special scan (x-ray) to measure their amount of body fat. The special x-ray is called "dual-energy x-ray absorptiometry" (DXA). They were asked to lie still on a table for x-ray pictures. Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Glucose
Glucose level, fasting blood draw Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Change in Lipoprotein Particle Subfraction Distribution
Lipoprotein insulin resistance (LPIR) score was calculated from triglyceride-rich, high-density, and low-density lipoprotein particle (TRL-P, HDL-P, LDL-P) sizes and subfraction concentrations (large/very large TRL-P, large HDL-P, small LDL-P). LPIR score is quantified on a scale of 0-100. Higher scores indicate worse outcome. Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Total Cholesterol
Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
HDL-Cholesterol
High-density lipoprotein cholesterol Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial.
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Non-HDL-Cholesterol
Calculated by subtracting HDL-cholesterol from total cholesterol. Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
LDL-Cholesterol
Low-density-lipoprotein cholesterol Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Adiponectin (Start of Trial)
Total and high molecular weight adiponectin Adiponectin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 20) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss)
Adiponectin (% Change)
Adiponeptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Change through 20 weeks' weight loss maintenance
C-reactive Protein (Start of Trial)
C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 22) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss)
C-reactive Protein (% Change)
C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Change through 20 weeks' weight loss maintenance
IL-6 (Start of Trial)
Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 24) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss)
IL-6 (% Change)
Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Change through 20 weeks' weight loss maintenance
Blood Pressure
Systolic and diastolic blood pressure Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Plasminogen Activator Inhibitor-1 (Start of Trial)
Plasminogen activator inhibitor-1 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 27) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss)
Plasminogen Activator Inhibitor-1 (% Change)
Plasminogen activator inhibitor-1 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
Time frame: Change through 20 weeks' weight loss maintenance
Fibrinogen
Change: end of test phase - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial)
Insulin level 30 minutes after consuming 75 grams of glucose
Time frame: Start of trial (time of randomization, post-weight loss)
Thyroxine (T4)
thyroid function test
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Free T4
free thyroxine, thyroid function test
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Thyroid Stimulating Hormone
Produced by the pituitary gland in the brain. Tells the thyroid gland to make thyroid hormones.
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Reverse T3
thyroid function test, inactive form of triiodothyronine (T3) Lifespan Bio kit was used for analysis. The range of this kit is 250 to 5000 pg/mL, which varies from other commercially available kits (about 10-fold greater values).
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Urinary Cortisol Excretion
cortisol (stress hormone) excreted in the urine over a 24-hour period
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Urinary Catecholamine - Adrenaline
catecholamine excreted in the urine over 24 hours, also known as epinephrine
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Urinary Catecholamine - Dopamine
catecholamine excreted in the urine over 24 hours
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Urinary Catecholamine - Noradrenaline
catecholamine excreted in the urine over 24 hours, also known as norepinephrine
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Insulin Sensitivity (Hepatic), Assessed by Frequently-sampled Oral Glucose Tolerance Test
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Insulin Sensitivity (Systemic), Assessed by Frequently-sampled Oral Glucose Tolerance Test
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Non-esterified Fatty Acids
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Serum Ketones/Ketoacids
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Lactate
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Metabolic Fuel Concentration in Serum (Glucose, Nonesterified Fatty Acids, Ketones/Ketoacids, Lactate)
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Insulin-like Growth Factor 1 (IGF-1)
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
IGF Binding Proteins
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Testosterone
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Estradiol
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Luteinizing Hormone
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Follicle Stimulating Hormone
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Body Weight Change During ad Libitum Feeding
Time frame: Ad libitum feeding period (weeks 21 and 22 following randomization)
Gut Microbiome Profile
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Serum Metabolomics Profile
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Change in Cognitive Function Related to Memory
California Verbal Learning Test - Second Edition \[CVLT-II\] and Digit Span Test
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Change in Cognitive Function Related to Processing Speed and Executive Function
Trail Making Test Parts A and B \[TMT-A, TMT-B\]
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Change in Self-reported Sleep Quality
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Change in Self-reported Depression Measure
Beck Depression Inventory-II \[BDI-II\]
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Change in Self-reported Mood/Anxiety
Mood and Anxiety Symptom Questionnaire \[MASQ\]
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Change in Self-reported Food Addiction Score
Yale Food Addiction Scale \[YFAS\]
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Change in Self-reported Emotional Eating Score
Emotional Eating Scale \[EES\]
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Change in Self-reported Binge Eating Score
Binge Eating Scale \[BES\]
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Effect Modification by Insulin Secretion of Metabolic Responses to Diet
Effect modifier: Insulin level 30 minutes into an standard OGTT (Insulin-30) Outcome: Total Energy Expenditure Tertiles: Pre-weight-loss Insulin-30 (Low, Moderate, High) Change: average (midpoint of test phase, end of test phase) - start of trial
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Effect Modification by Insulin Resistance of Metabolic Responses to Diet
Time frame: Start of (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
Effect Modification by Amylase Gene Copy Number
Time frame: Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance
We recruited participants by posting flyers, newspaper advertisements, and Internet announcements.
| Milestone | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Started | 57 | 53 | 54 |
| Provided data at midpoint test phase | 56 | 50 | 48 |
| Provided data at end of test phase | 54 | 48 | 46 |
| Included in intention-to-treat analysis | 56 | 52 | 54 |
| Completed | 54 | 48 | 46 |
| Not completed | 3 | 5 | 8 |
| Withdrew: Withdrew | 3 | 5 | 8 |
Total energy expenditure (TEE), assessed by indirect calorimetry using stable isotopes Total calories burned: Participants each drank about a cup of water containing special tracers which are measurable when they pass out of the body through urine. They provided a urine sample before they drank the water and then about every other day for the next two (2) weeks. Change: average (midpoint of test phase, end of test phase) - start of trial
| kcal/d | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of Trial | 2713 (2696 to 2730) | 2504 (2486 to 2522) | 2640 (2623 to 2657) |
| Change | 190 (109 to 270) | 71 (-12 to 155) | -19 (-104 to 66) |
Resting energy expenditure, assessed by indirect calorimetry using respiratory gas exchange Calories burned while resting: Participants lied down with head and neck under a clear plastic "bubble," breathing room air. Gases in expired air were collected. Change: average (midpoint of test phase, end of test phase) - start of trial
| kcal/d | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of Trial | 1615 (1609 to 1621) | 1576 (1569 to 1583) | 1603 (1597 to 1609) |
| Change | 54 (32 to 76) | 46 (23 to 69) | 34 (10 to 57) |
Actigraph Accelerometer Change: average (midpoint of test phase, end of test phase) - start of trial An Actigraph Accelerometer measures movement, similar to a pedometer. Data are reported as counts (divided by 1,000) per day. Each participant wore the the accelerometer on the right hip for 7 days at each time point.
| counts/d | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of Trial | 495.8 (489.5 to 502.1) | 463.8 (457.0 to 470.6) | 476.6 (470.4 to 482.8) |
| Change | -6.9 (-31.0 to 17.1) | -42.4 (-67.7 to -17.1) | -26.3 (-52.0 to -0.6) |
Efficiency is expressed as percentage ratio of power generated during cycle ergometry (with conversion of Watts to kcal/min using a factor of 0.01433) to energy expenditure above resting. Change: end of test phase - start of trial.
| % power generated to energy expended | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of Trial | 12.2 (12.1 to 12.3) | 11.7 (11.6 to 11.8) | 12.2 (12.1 to 12.3) |
| Change | 0.3 (-0.3 to 0.9) | -0.0 (-0.6 to 0.6) | -0.1 (-0.8 to 0.5) |
Leptin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 6) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
| ng/mL | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Leptin (Start of Trial) | 9.6 (9.2 to 10.0) | 9.8 (9.4 to 10.2) | 10.9 (10.5 to 11.3) |
Leptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
| % change | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Leptin (% Change) | 17.9 (7.7 to 29.1) | 34.8 (22.6 to 48.2) | 34.2 (21.8 to 47.7) |
Ghrelin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 8) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
| pg/mL | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Ghrelin (Start of Trial) | 598.2 (586.3 to 610.1) | 640.1 (626.4 to 653.8) | 693.2 (679.5 to 706.9) |
Ghrelin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial
| % change | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Ghrelin (% Change) | -11.8 (-14.8 to -8.6) | -8.7 (-12.0 to -5.3) | -4.9 (-8.4 to -1.2) |
Biomeasure of carbohydrate intake Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial
| ug/mL | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of Trial | 16.7 (16.2 to 17.2) | 17.2 (16.7 to 17.7) | 17.1 (16.7 to 17.6) |
| Change, 10 weeks | -2.5 (-3.0 to -2.0) | -1.2 (-1.7 to -0.7) | 0.1 (-0.4 to 0.6) |
| Change, 20 weeks | -3.5 (-4.2 to -2.8) | -1.8 (-2.6 to -1.1) | 0.6 (-0.2 to 1.3) |
Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial.
| % hemoglobin with glucose bound | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of Trial | 5.56 (5.52 to 5.60) | 5.58 (5.54 to 5.62) | 5.61 (5.57 to 5.65) |
| Change, 10 weeks | 0.01 (-0.02 to 0.04) | 0.03 (0.00 to 0.06) | -0.01 (-0.05 to 0.02) |
| Change, 20 weeks | -0.01 (-0.04 to 0.03) | 0.00 (-0.03 to 0.04) | -0.05 (-0.08 to -0.01) |
Triglyceride levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial
| md/dL | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of Trial | 77.3 (71.1 to 84.0) | 76.5 (70.2 to 83.3) | 80.5 (74.2 to 87.4) |
| Change, 10 weeks | -12.1 (-18.5 to -5.1) | 8.4 (0.0 to 17.5) | 10.9 (2.3 to 20.2) |
| Change, 20 weeks | -12.8 (-19.8 to -5.2) | -0.1 (-8.5 to 9.1) | 7.5 (-1.7 to 17.6) |
Body fat, presented as a % of total mass Participants each had a special scan (x-ray) to measure their amount of body fat. The special x-ray is called "dual-energy x-ray absorptiometry" (DXA). They were asked to lie still on a table for x-ray pictures. Change: end of test phase - start of trial
| % of total body mass | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of Trial | 36.2 (34.6 to 37.9) | 37.3 (35.1 to 39.5) | 37.8 (36.2 to 39.4) |
| Change | -0.3 (-0.7 to 0.2) | -0.3 (-0.7 to 0.1) | -0.5 (-1.0 to -0.1) |
Glucose level, fasting blood draw Change: end of test phase - start of trial
| mg/dL | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of Trial | 95.1 (92.9 to 97.2) | 94.3 (91.9 to 96.8) | 95.1 (92.9 to 97.3) |
| Change | 1.0 (-0.9 to 2.8) | -0.3 (-2.2 to 1.7) | -1.0 (-3.0 to 0.9) |
Lipoprotein insulin resistance (LPIR) score was calculated from triglyceride-rich, high-density, and low-density lipoprotein particle (TRL-P, HDL-P, LDL-P) sizes and subfraction concentrations (large/very large TRL-P, large HDL-P, small LDL-P). LPIR score is quantified on a scale of 0-100. Higher scores indicate worse outcome. Change: end of test phase - start of trial
| score on a scale (0-100) | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of trial | 34.6 (28.7 to 40.5) | 31.5 (26.1 to 36.9) | 31.4 (26.9 to 35.9) |
| Change | -5.3 (-9.2 to -1.5) | -0.02 (-4.1 to 4.1) | 3.6 (-0.6 to 7.7) |
Change: end of test phase - start of trial
| mg/dL | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of trial | 147.5 (140.2 to 154.9) | 145.5 (136.1 to 154.8) | 142.9 (135.1 to 150.8) |
| Change | 16.1 (11.5 to 20.7) | 18.5 (13.6 to 23.3) | 16.2 (11.2 to 21.1) |
High-density lipoprotein cholesterol Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial.
| md/dL | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of Trial | 47.8 (45.7 to 49.8) | 49.1 (47.0 to 51.2) | 47.6 (45.5 to 49.6) |
| Change, 10 weeks | 11.1 (9.4 to 12.8) | 6.9 (5.1 to 8.7) | 4.7 (2.9 to 6.5) |
| Change, 20 weeks | 13.0 (11.0 to 15.0) | 9.7 (7.6 to 11.8) | 6.8 (4.7 to 8.9) |
Calculated by subtracting HDL-cholesterol from total cholesterol. Change: end of test phase - start of trial
| mg/dL | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of trial | 101.5 (94.1 to 108.9) | 99.0 (90.6 to 107.5) | 98.2 (91.2 to 105.3) |
| Change | 6.3 (1.8 to 10.9) | 11.0 (6.3 to 15.8) | 9.5 (4.6 to 14.4) |
Low-density-lipoprotein cholesterol Change: end of test phase - start of trial
| mg/dL | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of trial | 80.6 (75.1 to 86.1) | 77.6 (70.3 to 84.9) | 79.5 (73.2 to 85.8) |
| Change | 10.0 (6.3 to 13.7) | 11.7 (7.8 to 15.7) | 8.2 (4.2 to 12.2) |
Total and high molecular weight adiponectin Adiponectin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 20) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
| ng/mL | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Total | 4.0 (3.0 to 5.9) | 5.1 (3.3 to 7.2) | 4.9 (3.5 to 5.9) |
| High Molecular Weight | 2.3 (1.4 to 3.5) | 2.8 (1.6 to 4.2) | 2.7 (1.9 to 3.6) |
Adiponeptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
| % change | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Total | 33.6 (24.9 to 42.9) | 17.4 (9.4 to 26.0) | 23.0 (14.5 to 32.3) |
| High Molecular Weight | 42.9 (33.3 to 53.1) | 27.6 (18.6 to 37.2) | 27.8 (18.7 to 37.7) |
C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 22) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
| mg/L | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| C-reactive Protein (Start of Trial) | 1.1 (0.6 to 2.5) | 1.5 (0.7 to 4.6) | 1.5 (0.6 to 3.1) |
C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
| % change | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| C-reactive Protein (% Change) | -9.9 (-24.2 to 7.1) | -20.6 (-33.8 to -4.8) | -1.7 (-18.6 to 18.6) |
Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 24) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
| pg/mL | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| IL-6 (Start of Trial) | 1.4 (1.0 to 2.4) | 1.8 (1.1 to 3.3) | 1.7 (1.0 to 2.6) |
Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
| % change | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| IL-6 (% Change) | -23.6 (-35.4 to -9.6) | -20.1 (-33.0 to -4.7) | -18.3 (-31.8 to -2.2) |
Systolic and diastolic blood pressure Change: end of test phase - start of trial
| mmHg | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Systolic, Start of trial | 117.2 (114.7 to 119.7) | 119.2 (115.9 to 122.5) | 114.3 (111.8 to 116.9) |
| Systolic, Change | -1.5 (-4.4 to 1.5) | 0.0 (-3.1 to 3.1) | 1.8 (-1.3 to 5.0) |
| Diastolic, Start of trial | 70.7 (68.3 to 73.1) | 73.7 (71.3 to 76.0) | 70.5 (68.3 to 72.7) |
| Diastolic, Change | 2.2 (-0.4 to 4.8) | 1.4 (-1.3 to 4.1) | 2.2 (-0.6 to 5.0) |
Plasminogen activator inhibitor-1 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 27) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial
| ng/mL | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Plasminogen Activator Inhibitor-1 (Start of Trial) | 1.1 (0.7 to 2.5) | 1.5 (0.7 to 3.1) | 1.2 (0.6 to 2.1) |
Plasminogen activator inhibitor-1 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial
| % change | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Plasminogen Activator Inhibitor-1 (% Change) | 7.2 (-14.7 to 34.8) | 26.9 (-0.2 to 61.4) | 14.9 (-10.1 to 46.9) |
Change: end of test phase - start of trial
| mg/dL | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of trial | 421.1 (398.2 to 443.9) | 461.0 (430.7 to 491.4) | 428.1 (400.9 to 455.2) |
| Change | -17.0 (-36.8 to 2.7) | -22.4 (-43.2 to -1.7) | -21.7 (-42.9 to -0.5) |
Insulin level 30 minutes after consuming 75 grams of glucose
| mIU/L | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Pre-weight loss | 131.4 (77.6 to 173.5) | 116.7 (86.8 to 218.5) | 99.2 (73.7 to 153.4) |
| Start of trial | 95.9 (55.5 to 131.3) | 79.9 (56.1 to 143.3) | 68.0 (57.0 to 106.6) |
| End of test phase | 96.2 (50.5 to 134.0) | 74.5 (51.3 to 135.4) | 74.8 (53.1 to 109.9) |
thyroid function test
| nmol/L | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Pre-weight loss | 85 (78 to 95) | 86 (78 to 97) | 90 (79 to 102) |
| Start of trial | 84 (75 to 96) | 85 (80 to 93) | 86 (78 to 96) |
| End of test phase | 85 (78 to 94) | 86 (80 to 98) | 85 (77 to 98) |
free thyroxine, thyroid function test
| pmol/L | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Pre-weight loss | 14.3 (13.1 to 15.9) | 15.0 (13.9 to 16.4) | 14.8 (13.5 to 16.1) |
| Start of trial | 14.9 (13.6 to 15.9) | 15.2 (15.0 to 16.9) | 15.0 (14.1 to 15.8) |
| End of test phase | 15.4 (14.0 to 16.6) | 15.7 (14.7 to 17.2) | 15.2 (14.0 to 16.1) |
Produced by the pituitary gland in the brain. Tells the thyroid gland to make thyroid hormones.
| ulU/ml | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Pre-weight loss | 2.0 (1.6 to 2.6) | 1.8 (1.4 to 2.5) | 2.1 (1.3 to 3.2) |
| Start of trial | 2.1 (1.5 to 2.9) | 2.2 (1.5 to 2.7) | 2.5 (1.7 to 3.0) |
| End of test phase | 2.0 (1.5 to 2.5) | 1.7 (1.4 to 2.7) | 2.1 (1.4 to 3.5) |
thyroid function test, inactive form of triiodothyronine (T3) Lifespan Bio kit was used for analysis. The range of this kit is 250 to 5000 pg/mL, which varies from other commercially available kits (about 10-fold greater values).
| pg/mL | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Pre-weight loss | 1499 (1306 to 1610) | 1548 (1429 to 1676) | 1536 (1410 to 1756) |
| Start of trial | 1545 (1356 to 1687) | 1554 (1383 to 1768) | 1548 (1378 to 1733) |
| End of test phase | 1557 (1375 to 1702) | 1572 (1404 to 1795) | 1546 (1332 to 1686) |
cortisol (stress hormone) excreted in the urine over a 24-hour period
| μg/d | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Pre-weight loss | 61 (48 to 78) | 59 (41 to 80) | 63 (45 to 91) |
| Start of trial | 66 (48 to 83) | 64 (47 to 88) | 63 (50 to 77) |
| End of test phase | 78 (56 to 100) | 64 (50 to 94) | 64 (45 to 84) |
catecholamine excreted in the urine over 24 hours, also known as epinephrine
| mcg/day | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Pre-weight loss | 3.1 (2.4 to 4.1) | 3.0 (2.2 to 4.2) | 2.9 (2.2 to 3.6) |
| Start of trial | 3.5 (2.7 to 4.7) | 3.2 (2.3 to 4.3) | 3.0 (2.2 to 3.5) |
| End of test phase | 3.6 (2.6 to 5.3) | 3.4 (2.3 to 4.7) | 3.1 (2.3 to 4.1) |
catecholamine excreted in the urine over 24 hours
| mcg/day | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Pre-weight loss | 142.0 (105.7 to 187.5) | 143.2 (83.2 to 187.8) | 117.8 (92.7 to 163.6) |
| Start of trial | 112.9 (75.1 to 157.6) | 112.4 (85.7 to 135.3) | 104.7 (76.0 to 125.9) |
| End of test phase | 123.0 (86.4 to 159.1) | 112.9 (90.5 to 156.6) | 104.7 (83.9 to 141.7) |
catecholamine excreted in the urine over 24 hours, also known as norepinephrine
| mcg/day | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Pre-weight loss | 25.8 (18.9 to 34.2) | 23.9 (18.9 to 31.6) | 25.3 (19.8 to 31.1) |
| Start of trial | 25.2 (19.4 to 31.6) | 25.3 (20.1 to 31.7) | 24.7 (17.5 to 30.5) |
| End of test phase | 27.4 (18.8 to 36.1) | 26.1 (20.6 to 36.9) | 26.0 (19.5 to 32.4) |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
California Verbal Learning Test - Second Edition \[CVLT-II\] and Digit Span Test
Results for this outcome have not been posted.
Trail Making Test Parts A and B \[TMT-A, TMT-B\]
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Beck Depression Inventory-II \[BDI-II\]
Results for this outcome have not been posted.
Mood and Anxiety Symptom Questionnaire \[MASQ\]
Results for this outcome have not been posted.
Yale Food Addiction Scale \[YFAS\]
Results for this outcome have not been posted.
Emotional Eating Scale \[EES\]
Results for this outcome have not been posted.
Binge Eating Scale \[BES\]
Results for this outcome have not been posted.
Effect modifier: Insulin level 30 minutes into an standard OGTT (Insulin-30) Outcome: Total Energy Expenditure Tertiles: Pre-weight-loss Insulin-30 (Low, Moderate, High) Change: average (midpoint of test phase, end of test phase) - start of trial
| kcal/d | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|
| Start of Trial, Low Insulin-30 | 2795 (2591 to 2998) | 2673 (2456 to 2891) | 2647 (2463 to 2832) |
| Change, Low Insulin-30 | 147 (-1 to 295) | 103 (-44 to 250) | 15 (-119 to 148) |
| Start of Trial, Moderate Insulin-30 | 2816 (2597 to 3035) | 2563 (2377 to 2750) | 2782 (2571 to 2993) |
| Change, Moderate Insulin-30 | 114 (-37 to 266) | -5 (-136 to 127) | -50 (-200 to 101) |
| Start of Trial, High Insulin-30 | 2643 (2461 to 2826) | 2281 (2053 to 2508) | 2544 (2331 to 2757) |
| Change, High Insulin-30 | 271 (145 to 396) | 141 (-20 to 303) | -37 (-201 to 127) |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Run-in Phase | 0/234 (0%) | 0/234 (0%) | 28/234 (12%) |
| Low Carbohydrate Diet | 0/57 (0%) | 0/57 (0%) | 5/57 (8.8%) |
| Moderate Carbohydrate Diet | 0/53 (0%) | 0/53 (0%) | 6/53 (11.3%) |
| High Carbohydrate Diet | 0/54 (0%) | 2/54 (3.7%) | 1/54 (1.9%) |
| Event | Run-in Phase | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|---|
| Laparoscopic cholecystectomySurgical and medical procedures | 0/234 | 0/57 | 0/53 | 1/54 |
| Removal of intrauterine deviceReproductive system and breast disorders | 0/234 | 0/57 | 0/53 | 1/54 |
| Event | Run-in Phase | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet |
|---|---|---|---|---|
| Food allergy, aversion or intoleranceImmune system disorders | 4/234 | 2/57 | 2/53 | 1/54 |
| Back painMusculoskeletal and connective tissue disorders | 0/234 | 2/57 | 0/53 | 0/54 |
| Vasovagal reactionNervous system disorders | 4/234 | 1/57 | 1/53 | 0/54 |
| LightheadednessGeneral disorders | 0/234 | 0/57 | 1/53 | 0/54 |
| Bone fractureMusculoskeletal and connective tissue disorders | 1/234 | 0/57 | 1/53 | 0/54 |
| PericarditisInfections and infestations | 0/234 | 0/57 | 1/53 | 0/54 |
| HematomaGeneral disorders | 3/234 | 0/57 | 0/53 | 0/54 |
| VomitingGeneral disorders | 2/234 | 0/57 | 0/53 | 0/54 |
| ConstipationGastrointestinal disorders | 1/234 | 0/57 | 0/53 | 0/54 |
| GastroenteritisGastrointestinal disorders | 1/234 | 0/57 | 0/53 | 0/54 |
| Age, Categorical(Participants) | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 57 | 53 | 54 | 164 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet | Total |
|---|---|---|---|---|
| Mean | 37.1 ± 13.3 | 37.3 ± 14.9 | 39.8 ± 15.1 | 37.8 ± 14.4 |
| Sex: Female, Male(Participants) | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet | Total |
|---|---|---|---|---|
| Female | 37 | 36 | 42 | 115 |
| Male | 20 | 17 | 12 | 49 |
| Ethnicity (NIH/OMB)(Participants) | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet | Total |
|---|---|---|---|---|
| Hispanic or Latino | 10 | 7 | 8 | 25 |
| Not Hispanic or Latino | 47 | 46 | 46 | 139 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet | Total |
|---|---|---|---|---|
| United States | 57 | 53 | 54 | 164 |
| Total Energy Expenditure(kcal/d) | Low Carbohydrate Diet | Moderate Carbohydrate Diet | High Carbohydrate Diet | Total |
|---|---|---|---|---|
| Mean | 3110 ± 680 | 3030 ± 788 | 2915 ± 686 | 3021 ± 719 |
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Boston Children's Hospital