An interventional study of Feeding Study in Obesity, sponsored by Boston Children's Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-18.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
Among 19 studies in Obesity by Boston Children's Hospital — 2 open to participants now, 2 under way, none of them phase 3. Obesity · Boston Children's Hospital.
Among the 19 studies in Obesity by Boston Children's Hospital, this one is the 7th largest by enrollment of the 18 interventional ones that give a count, is the only one that started in 2018, is one of 19 with no phase, and was the 16th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →2 of the 19 studies in Obesity by Boston Children's Hospital are open now, in 1 country. Recruiting first, the newest first:
Boston Children's Hospital · Sites in United States
Boston Children's Hospital · Sites in United States
By country, each count listing its studies:
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2018.
This study's enrollment of 166 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 123 across the 18 interventional studies. Of the 17 that completed or were terminated, 3 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
1 of the studies in Obesity by Boston Children's Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05464186Boston Children's HospitalEffects of Whole vs. Nonfat Milk Consumption on Body Composition in Children | 2026-12 |
Among the 19 studies in Obesity by Boston Children's Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This study will evaluate the effects of dietary carbohydrate and sugar consumption, independent of energy content, on body fatness and metabolism in a rigorous feeding study.
Many people with obesity can lose weight for a few months, but most have difficulty maintaining weight loss over the long term. Extensive research has shown that weight loss elicits biological adaptations - including a decline in energy expenditure and an increase in hunger - that promote weight regain. However, this observation leaves unanswered why average body weight has recently increased among populations that are mostly genetically stable. According to the Carbohydrate-Insulin Model, increased consumption of processed carbohydrates during the low-fat diet era of the last 40 years has raised the average body weight being defended by biological mechanisms on a population basis. Specifically, the investigators hypothesize that diets high in total carbohydrate (with or without added sugar) acting through increased insulin secretion, alter substrate partitioning toward storage in body fat, leading to increased hunger, slowing metabolism, and accumulation of body fat.
To test this hypothesis, the investigators plan a randomized-controlled feeding study involving 125 adults with obesity. During the run-in phase, participants will be given a hypocaloric very-low-carbohydrate (VLC) diet, with adjustment of energy intake to produce 15 ± 3% weight loss over 3 to 4 months on an outpatient basis. After weight stabilization, participants will be admitted to a residential center for 13 weeks. During the first 3 weeks, energy intake and expenditure will be closely monitored during weight-loss maintenance. Then, energy intake will be individually "locked" at levels equal to energy expenditure and participants will be administered one of three randomly-assigned test diets for 10 weeks. The test diets include VLC, High Carbohydrate-Low Sugar (HC-LS), and High Carbohydrate-High Sugar (HC-HS).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Female-specific exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Feeding study. Dietary composition (approximately): 75% fat
Behavioral: Feeding Study
Feeding study. Dietary composition (approximately): 25% fat 0% added sugars.
Behavioral: Feeding Study
Feeding study. Dietary composition (approximately): 25% fat, 20% added sugars.
Behavioral: Feeding Study
Food provision throughout the study: 1) Run-In Phase (VLC diet, weight loss); 2) Residential Phase (3 different test diets, weight-loss maintenance).
Also known as: weight loss, weight-loss maintenance
Body fat mass
Body composition assessed using a multi-component model
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Lean body mass
Assessed using a multi-component model (difference between total body mass and fat mass)
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Body weight
Anthropometrics, assessed by calibrated scale, in kilograms (kg)
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Total energy expenditure (TEE)
Assessed using doubly labeled water methodology
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Resting energy expenditure (REE)
Assessed by indirect calorimetry using respiratory gas exchange methodology with a ventilated hood system
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Physical activity level, (moderate to vigorous)
Total minutes of moderate- to vigorous-intensity physical activity, assessed by accelerometry
Time frame: Measurements made daily during 2 weeks at PWL, 2 weeks at END, and alternating non-assessment weeks of the residential phase and integrated into a unified outcome
Insulin sensitivity
Assessed by frequently-sampled oral glucose tolerance test \[OGTT\], calculated using plasma insulin and glucose values
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Insulin secretion
Assessed by frequently-sampled oral glucose tolerance test \[OGTT\], using plasma insulin at 30 minutes following the dose of dextrose
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Glycemic control
Hemoglobin A1c \[HbA1c\]
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Total cholesterol
Chronic disease risk factor
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
HDL-cholesterol
Chronic disease risk factor
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
LDL-cholesterol
Chronic disease risk factor
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Non-HDL cholesterol
Chronic disease risk factor
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Triglycerides
Chronic disease risk factor
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Plasminogen Activator Inhibitor-1 [PAI-1]
Indicator of coagulopathy
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
High-sensitivity C-reactive protein [hsCRP]
Indicator of chronic inflammation
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Uric acid
Indicator of risk for kidney stones, measured in blood
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Systolic blood pressure
Assessed by auscultation, mmHg
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Diastolic blood pressure
Assessed by auscultation, mmHg
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Thyroxine (T4)
Thyroid function
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Free T4
Thyroid function
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Thyroid stimulating hormone [TSH]
Thyroid function
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Insulin-like growth factor-1 [IGF-1]
Growth hormone action
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Urine cortisol
Stress hormone, assessed using 24-hour urine collection
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Urine catecholamines
Stress hormone, assessed using 24-hour urine collection
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Leptin
Adipokine
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Total Adiponectin
Adipokine
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
High-molecular weight adiponectin
Adipokine
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Sleep
Total sleep time, sleep onset latency, wake after sleep onset, and sleep efficiency, assessed by accelerometry
Time frame: Measurements made daily during 2 weeks at PWL, 2 weeks at END, and alternating non-assessment weeks of the residential phase and integrated into a unified outcome
Blood glucose
Assessed by continuous glucose monitoring (CGM)
Time frame: Measurements made daily during residential phase (0 to 10 weeks) and integrated into a unified outcome
Ghrelin
Hormonal Control of Appetite
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Body Circumference
Assessed using a 3D body scan
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Post-prandial energy expenditure and respiratory quotient
Optional testing, assessed by indirect calorimetry using respiratory gas exchange
Time frame: Single assessment in weeks 6 to 8 of residential study
Activation of insulin signaling pathways
Assessed by immunohistochemistry of phosphorylated insulin receptor and signaling proteins
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
1,5-anhydroglucitol (1,5-AG)
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Lipoprotein particle subfraction distribution
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Fibrinogen
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Interleukin-6 (IL-6)
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Reverse triiodothyronine (rT3)
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Insulin-like growth factor-binding protein 3 (IGF-BP3)
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Luteinizing hormone (LH)
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Follicle stimulating hormone (FSH)
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Estradiol (E2)
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Testosterone (TST, total)
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Testosterone (TST, free)
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Metabolomics profile
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Biomarker of cholesterol synthesis
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Biomarker of cholesterol absorption
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
MicroRNA
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Gut microbiome
Possible future analyses of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Demographics (mediator/modifier)
Baseline covariate
Time frame: Pre-weight loss baseline
Body composition (mediator/modifier)
Baseline covariate
Time frame: Pre-weight loss baseline
Measure of glucose homeostasis (insulin-30) (mediator/modifier)
Baseline covariate
Time frame: Pre-weight loss baseline
Measure of glucose homeostasis (insulin sensitivity) (mediator/modifier)
Baseline covariate
Time frame: Pre-weight loss baseline
Measure of glucose homeostasis (glycemic control) (mediator/modifier)
Baseline covariate
Time frame: Pre-weight loss baseline
Obesity related genetic risk (mediator/modifier)
Baseline covariate
Time frame: Pre-weight loss baseline
Body composition (mediator/modifier)
Time varying covariate
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Measure of glucose homeostasis (insulin-30) (mediator/modifier)
Time varying covariate
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Measure of glucose homeostasis (insulin sensitivity) (mediator/modifier)
Time varying covariate
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Measure of glucose homeostasis (glycemic control) (mediator/modifier)
Time varying covariate
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Physical activity level (moderate to vigorous) (mediator/modifier)
Time varying covariate for total minutes of moderate to vigorous intensity physical activity, assessed by accelerometry.
Time frame: Measurements made daily during 2 weeks at PWL, 2 weeks at END, and alternating non-assessment weeks of the residential phase and integrated into a unified outcome
Sex Hormone-Binding Globulin (SHBG)
Possible future analysis of archived specimen
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Urinary nitrogen
Archived for future analysis
Time frame: End of residential (END, 10 weeks)
Glucagon-like peptide-1 (GLP-1)
Possible future analyses of archived samples
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Glucose-dependent insulinotropic polypeptide (GIP)
Possible future analyses of archived samples
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Glucagon
Possible future analyses of archived samples
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Oxytocin
Possible future analyses of archived samples
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Oxyntomodulin
Possible future analyses of archived samples
Time frame: Change from post-weight loss (PWL, 0 weeks) to end of residential study (END, 10 weeks)
Ran from May 2018 to primary completion in May 2020, 23 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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