CClinicalTrials.gg
Sign In
CompletedNCT00609271MACROUpdated Nov 19, 2018Results posted

Study of Macronutrients and Heart Disease Risk

An interventional study of low carbohydrate diet and low fat diet in Obesity, Body Composition and Blood Pressure, sponsored by Tulane University Health Sciences Center. Completed at 1 site in United States. Open to participants aged 22 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-19.

Sponsored by Tulane University Health Sciences Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
22 Years to 75 Years
Sex
All
01

Study summary

The objective of this trial is to examine the long-term effects of a diet low in carbohydrates, as compared to one low in fat, on cardiovascular disease risk factors, including blood pressure (BP), body weight and composition, serum lipids, plasma glucose, insulin, adipocytokines (adiponectin, leptin, resistin), and C-reactive protein (CRP) among obese adults.

The investigators will test the following hypotheses:

Hypothesis 1: Compared to a low fat diet, a diet low in carbohydrates will reduce systolic and diastolic BP over 12 months; Hypothesis 2: Compared to a low fat diet, a diet low in carbohydrates will reduce body weight, total percent body fat, and waist circumference over 12 months; Hypothesis 3: Compared to a low fat diet, a diet low in carbohydrates will reduce serum levels of LDL-cholesterol and triglycerides and increase serum levels of HDL-cholesterol over 12 months; Hypothesis 4: Compared to a low fat diet, a diet low in carbohydrates will reduce plasma levels of glucose and insulin levels over 12 months; and Hypothesis 5: Compared to a low fat diet, a diet low in carbohydrates will reduce plasma levels of leptin, resistin, and CRP and increase plasma levels of adiponectin over 12 months.

Read the detailed description

Cardiovascular diseases (CVD) remain the leading cause of death globally as well as here in the United States. Manipulations of the macronutrient (protein, carbohydrate and fat) contents of diet have been used extensively for weight loss and weight control in the past several decades. Low carbohydrate diets, in particular, have gained popularity for weight loss. However, few studies have examined the effects of a diet low in carbohydrates on traditional and novel cardiovascular risk factors in the long term, particularly in contrast to the current dietary recommendations for decreased fat intake to reduce risk of CVD. In this proposal, we plan to conduct a 12-month, parallel-arm, randomized controlled trial of a diet low in carbohydrates versus the currently recommended low fat diet to reduce CVD risk factors among obese adults. The objective of this trial is to examine the long-term effects of a diet low in carbohydrates, as compared to one low in fat, on CVD risk factors, including blood pressure (BP), body weight and composition, serum lipids, plasma glucose, insulin, adipocytokines (adiponectin, leptin, resistin), and C-reactive protein (CRP) among obese adults. In order to accomplish these objectives we will randomize 130 eligible participants (n=65 in each group) to consume either a diet low in carbohydrates (≤40 g/d) or a diet low in fat (\<7% saturated fat, \<30% total fat). Neither of the diets will be energy-restricted. Participants will meet with a dietitian for one-on-one counseling sessions weekly for the first 4 weeks, then bi-monthly in small group sessions for the next 5 months, and monthly in larger group sessions for the final 6 months of the intervention. Data on both traditional and novel CVD risk factors will be collected at baseline, 3, 6, and 12 months. We hypothesize that a diet low in carbohydrates as compared to a diet low in fat will lower systolic and diastolic BP, body weight, total percent body fat, waist circumference, serum levels of triglycerides, and plasma levels of insulin, glucose, leptin, resistin, and CRP, and increase serum levels of HDL-cholesterol and adiponectin. Because CVD is the most common cause of death here in the U.S. and world-wide, this study has important public health implications. It will provide new information on the potential long-term effects of diets low in carbohydrates on both the traditional risk factors for CVD as well as novel risk factors and inflammatory factors. The results from this study will help to determine if a diet low in carbohydrates as compared to the currently recommended low fat diet can decrease the risk of CVD among obese adults.

02

Conditions studied

  • Obesity
  • Body Composition
  • Blood Pressure
  • Cardiovascular Diseases
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 148 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Tulane University Health Sciences Center is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Men or women aged 22 - 75 years, any race/ethnicity
  • BMI of 30 - 45 k/m2
  • Willing and able to provide informed consent

Exclusion criteria

Exclusion Criteria:

  • History of self-reported clinical CVD (angina/myocardial infarction, coronary revascularization, heart failure, stroke/transient ischemic attack, peripheral arterial disease)
  • Medical condition in which a low-carbohydrate diet may not be advised (diabetes, renal disease, cancer requiring treatment during the past year, osteoporosis, untreated thyroid disease, gout)
  • Current use of more than 2 antihypertensive or more than 2 cholesterol-lowering medications
  • For women, current pregnancy or breastfeeding or plans to become pregnant during the study period
  • Consumption of more than 21 alcoholic beverages per week
  • Currently on a diet or using prescription weight loss medications, underwent weight loss surgery, and/or experienced weight loss >15 pounds within 6 months of study entry
  • Plans to move out of the study area (>1 hour from study site) or difficulty to come to the study site
  • Participation of another household member in the study; employees or persons living with employees of the study
  • Participation in other lifestyle intervention trials currently
  • At the discretion of the study coordinator
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
148 participants (actual)

Study arms

  • Experimental
    1

    low carbohydrate diet

    Behavioral: low carbohydrate diet

  • Active comparator
    2

    low fat diet

    Behavioral: low fat diet

Interventions

  • Behaviorallow carbohydrate diet

    \<40 grams carbohydrate/day

  • Behaviorallow fat diet

    \<30% fat, \<7% saturated fat

06

What researchers measure

Primary outcomes

  1. Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group

    Predicted mean difference from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

    Time frame: 12 months

  2. Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group

    Mean Difference in Lean Mass predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

    Time frame: 12 months

  3. Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group

    Mean Difference in Fat Mass predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

    Time frame: 12 months

  4. Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group

    Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

    Time frame: 12 months

  5. Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group

    Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

    Time frame: 12 months

  6. Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group

    Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

    Time frame: 12 months

  7. Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group

    Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

    Time frame: 12 months

  8. Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group

    Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

    Time frame: 12 months

  9. Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group

    Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

    Time frame: 12 months

  10. Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group

    Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

    Time frame: 12 months

  11. Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group

    Mean Difference in Diastolic Blood Pressure predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values

    Time frame: 12 Months

  12. Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group

    Mean Difference in Plasma Glucose Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

    Time frame: 12 months

  13. Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group

    Mean Difference in Serum Insulin Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

    Time frame: 12 months

  14. Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group

    Mean Difference in C-reactive Protein Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values

    Time frame: 12 Months

  15. Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group

    Mean Difference in Serum Creatinine Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

    Time frame: 12 Months

  16. Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group

    Mean Difference in 10-y Framingham Risk Score predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

    Time frame: 12 Months

07

Results

Posted Nov 19, 2018

Participant flow

Participant flow — Overall Study
MilestoneLow Carbohydrate DietLow Fat Diet
Started7573
Completed5960
Not completed1613

Outcome measures

PrimaryPredicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group

Predicted mean difference from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

Time frame:
12 months
Reported as:
Mean · kg
Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group
kgLow Carbohydrate DietLow Fat Diet
Change in body weight after 3 months-5.7 (-6.5 to -4.9)-2.6 (-3.4 to -1.7)
Change in body weight after 6 months-5.6 (-6.5 to -4.6)-2.3 (-3.3 to -1.3)
Change in body weight after 12 months-5.3 (-6.8 to -3.8)-1.8 (-3.3 to -0.3)
PrimaryPredicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group

Mean Difference in Lean Mass predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

Time frame:
12 months
Reported as:
Mean · % of body weight that is lean mass
Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group
% of body weight that is lean massLow Carbohydrate DietLow Fat Diet
Change of % lean mass after 3 months1.6 (1.0 to 2.2)0.4 (-0.2 to 1.1)
Change of % lean mass after 6 months1.5 (0.9 to 2.1)0.2 (-0.4 to 0.7)
Change of % lean mass after 12 months1.3 (0.5 to 2.0)-0.4 (-1.2 to 0.4)
PrimaryPredicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group

Mean Difference in Fat Mass predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

Time frame:
12 months
Reported as:
Mean · % body weight that is fat mass
Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group
% body weight that is fat massLow Carbohydrate DietLow Fat Diet
Change of % fat mass after 3 months-1.1 (-1.7 to -.05)-0.3 (-0.9 to 0.3)
Change of % fat mass after 6 months-1.1 (-1.7 to -0.6)-0.1 (-0.6 to 0.5)
Change of % fat mass after 12 months-1.2 (-2.0 to -0.4)0.3 (-0.5 to 1.1)
PrimaryPredicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group

Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

Time frame:
12 months
Reported as:
Mean · cm
Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group
cmLow Carbohydrate DietLow Fat Diet
Change in waist circumference after 3 mo-5.5 (-6.6 to -4.4)-3.5 (-4.6 to -2.4)
Change in waist circumference after 6 mo-5.9 (-7.1 to -4.7)-4.0 (-5.2 to -2.8)
Change in waist circumference after 12 mo-6.7 (-8.5 to -4.9)-5.0 (-6.8 to -3.2)
PrimaryPredicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group

Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

Time frame:
12 months
Reported as:
Mean · mmol/L
Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group
mmol/LLow Carbohydrate DietLow Fat Diet
Change of total cholesterol after 3 mo-0.09 (-0.21 to 0.04)0.03 (-0.10 to 0.16)
Change of total cholesterol after 6 mo-0.04 (-0.16 to 0.07)0.03 (-0.09 to 0.15)
Change of total cholesterol after 12 mo0.05 (-0.11 to 0.20)0.03 (-0.13 to 0.18)
PrimaryPredicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group

Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

Time frame:
12 months
Reported as:
Mean · mmol/L
Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group
mmol/LLow Carbohydrate DietLow Fat Diet
Change in LDL cholesterol level after 3 mo-0.02 (-0.14 to 0.10)0.05 (-0.06 to 0.18)
Change in LDL cholesterol level after 6 mo-0.04 (-0.15 to 0.06)0.02 (-0.08 to 0.13)
Change in LDL cholesterol level after 12 mo-0.08 (-0.24 to 0.08)-0.05 (-0.20 to 0.11)
PrimaryPredicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group

Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

Time frame:
12 months
Reported as:
Mean · mmol/L
Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group
mmol/LLow Carbohydrate DietLow Fat Diet
Change in HDL cholesterol level after 3 mo0.03 (-0.02 to 0.09)-0.03 (-0.09 to 0.02)
Change in HDL cholesterol level after 6 mo0.10 (0.05 to 0.15)-0.00 (-0.05 to 0.05)
Change in HDL cholesterol level after 12 mo0.24 (0.17 to 0.31)0.06 (-0.01 to 0.13)
PrimaryPredicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group

Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

Time frame:
12 months
Reported as:
Mean · ratio
Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group
ratioLow Carbohydrate DietLow Fat Diet
Change in Total-HDL cholesterol ratio after 3 mo-0.13 (-0.28 to 0.03)0.13 (-0.02 to 0.29)
Change in Total-HDL cholesterol ratio after 6 mo-0.25 (-0.38 to -0.11)0.07 (-0.06 to 0.21)
Change in Total-HDL cholesterol level after 12 mo-0.49 (-0.68 to -0.29)-0.05 (-0.24 to 0.14)
PrimaryPredicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group

Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

Time frame:
12 months
Reported as:
Mean · mmol/L
Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group
mmol/LLow Carbohydrate DietLow Fat Diet
Change in Triglycerides after 3 mo-0.21 (-0.32 to -0.11)0.03 (-0.08 to 0.14)
Change in Triglycerides after 6 mo-0.22 (-0.31 to -0.13)-0.01 (-0.10 to 0.09)
Change in Triglycerides after 12 mo-0.23 (-0.34 to -0.12)-0.07 (-0.18 to 0.04)
PrimaryPredicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group

Predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

Time frame:
12 months
Reported as:
Mean · mm Hg
Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group
mm HgLow Carbohydrate DietLow Fat Diet
Change in Systolic Blood Pressure after 3 mo-4.2 (-5.9 to -2.5)-2.6 (-4.3 to -0.9)
Change in Systolic Blood Pressure after 6 mo-2.9 (-4.5 to -1.3)-2.2 (-3.8 to -0.6)
Change in Systolic Blood Pressure after 12 mo-0.2 (-2.6 to 2.1)-1.3 (-3.6 to 1.0)
PrimaryPredicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group

Mean Difference in Diastolic Blood Pressure predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values

Time frame:
12 Months
Reported as:
Mean · mm Hg
Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group
mm HgLow Carbohydrate DietLow Fat Diet
Change in Diastolic Blood Pressure after 3 mo-2.3 (-3.5 to -1.1)-0.9 (-2.1 to 0.4)
Change in Diastolic Blood Pressure after 6 mo-1.7 (-2.8 to -0.5)-0.5 (-1.7 to 0.6)
Change in Diastolic Blood Pressure after 12 mo-0.5 (-2.2 to 1.3)0.2 (-1.5 to 1.9)
PrimaryPredicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group

Mean Difference in Plasma Glucose Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

Time frame:
12 months
Reported as:
Mean · mmol/L||
Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group
mmol/L||Low Carbohydrate DietLow Fat Diet
Change in Plasma Glucose Level after 3 months-0.05 (-0.16 to 0.05)-0.10 (-0.21 to 0.01)
Change in Plasma Glucose Level after 6 months0.03 (-0.13 to 0.07)-0.10 (-0.20 to 0.01)
Change in Plasma Glucose Level after 12 months0.02 (-0.11 to 0.14)-0.10 (-0.22 to 0.03)
PrimaryPredicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group

Mean Difference in Serum Insulin Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

Time frame:
12 months
Reported as:
Mean · pmol/L
Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group
pmol/LLow Carbohydrate DietLow Fat Diet
Change in Serum Insulin Level after 3 mo-25.0 (-36.1 to -13.9)-18.8 (-29.9 to -7.0)
Change in Serum Insulin Level after 6 mo-21.5 (-31.3 to -11.8)-20.8 (-30.6 to -11.1)
Change in Serum Insulin Level after 12 mo-13.9 (-25.7 to -2.8)-24.3 (-36.1 to -13.2)
PrimaryPredicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group

Mean Difference in C-reactive Protein Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values

Time frame:
12 Months
Reported as:
Mean · nmol/L
Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group
nmol/LLow Carbohydrate DietLow Fat Diet
Change in Serum Creatinine Level after 3 mo-4.8 (-13.3 to 3.8)5.7 (-2.9 to 13.3)
Change in Serum Creatinine Level after 6 mo-4.8 (-12.4 to 1.9)6.7 (-1.0 to 13.3)
Change in Serum Creatinine Level after 12 mo-6.7 (-16.2 to 2.9)8.6 (-1.0 to 18.1)
PrimaryPredicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group

Mean Difference in Serum Creatinine Level predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

Time frame:
12 Months
Reported as:
Mean · µmol/L¶
Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group
µmol/L¶Low Carbohydrate DietLow Fat Diet
hange in Serum Creatinine Level after 3 mo-0.1 (-3.4 to 3.3)1.8 (-1.7 to 5.2)
hange in Serum Creatinine Level after 6 mo-3.1 (-6.1 to -0.2)-1.7 (-4.7 to 1.3)
hange in Serum Creatinine Level after 12 mo-9.2 (-13.1 to -5.4)-8.5 (-12.3 to -4.6)
PrimaryPredicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group

Mean Difference in 10-y Framingham Risk Score predicted from random-effects models that included diet, time, and diet-by-time interaction term. Markov-chain Monte Carlo techniques were used to impute missing values.

Time frame:
12 Months
Reported as:
Mean · % risk of developing CVD in next 10 yrs
Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group
% risk of developing CVD in next 10 yrsLow Carbohydrate DietLow Fat Diet
Change in 10-Y Framingham Risk Score after 3 mo-0.5 (-1.0 to 0.0)0.4 (-0.1 to 0.9)
Change in 10-Y Framingham Risk Score after 6 mo-0.7 (-1.0 to -0.3)0.4 (0.0 to 0.8)
Change in 10-Y Framingham Risk Score after 12 mo-1.0 (-1.6 to -0.5)0.4 (-0.2 to 0.9)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Low Carbohydrate Diet—0/75 (0%)19/75 (25.3%)
Low Fat Diet—0/73 (0%)23/73 (31.5%)
Most frequent other events
Showing 10 of 33
Most frequent other events
EventLow Carbohydrate DietLow Fat Diet
Gas at 12 monthsGastrointestinal disorders16/7523/73
Fatigue at 6 monthsGeneral disorders18/7522/73
Headache at 12 monthsGeneral disorders11/7522/73
Gas at 6 monthsGastrointestinal disorders17/7522/73
Constipation at 6 monthsGastrointestinal disorders18/7519/73
Constipation at 3 monthsGastrointestinal disorders19/7513/73
Gas at 3 monthsGastrointestinal disorders19/7515/73
Headache at 3 monthsGeneral disorders6/7518/73
Heartburn at 12 monthsGastrointestinal disorders9/7518/73
Constipation at 12 monthsGastrointestinal disorders1/7517/73

Baseline characteristics

Age, Continuous
Age, Continuous(years)Low Carbohydrate DietLow Fat DietTotal
Mean45.8 ± 9.947.8 ± 10.446.8 ± 10.2
Sex: Female, Male
Sex: Female, Male(Participants)Low Carbohydrate DietLow Fat DietTotal
Female6665131
Male9817
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Low Carbohydrate DietLow Fat DietTotal
White343367
Black403676
Asian101
Hispanic033
Other011
body weight
body weight(kg)Low Carbohydrate DietLow Fat DietTotal
Mean96.3 ± 12.797.9 ± 13.597.1 ± 13.1
body composition
body composition(%)Low Carbohydrate DietLow Fat DietTotal
Fat mass40 ± 1040 ± 1040 ± 10
Lean Mass60 ± 1060 ± 1060 ± 10
body mass index
body mass index(kg/m**2)Low Carbohydrate DietLow Fat DietTotal
Mean35.2 ± 3.835.6 ± 4.535.4 ± 4.2
waist circumference
waist circumference(cm)Low Carbohydrate DietLow Fat DietTotal
Mean108.4 ± 9.3111.0 ± 10.7109.7 ± 10.1
systolic blood pressure
systolic blood pressure(mm Hg)Low Carbohydrate DietLow Fat DietTotal
Mean120.3 ± 12.8124.9 ± 13.8122.6 ± 13.5

13 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Tulane University, Office of Health Research
    New Orleans, Louisiana 70112, United States
09

References and documents

Publications

  • Hu T, Yao L, Reynolds K, Niu T, Li S, Whelton P, He J, Bazzano L. The effects of a low-carbohydrate diet on appetite: A randomized controlled trial. Nutr Metab Cardiovasc Dis. 2016 Jun;26(6):476-88. doi: 10.1016/j.numecd.2015.11.011. Epub 2015 Dec 12. PubMed 26803589 ↗
  • Bazzano LA, Hu T, Reynolds K, Yao L, Bunol C, Liu Y, Chen CS, Klag MJ, Whelton PK, He J. Effects of low-carbohydrate and low-fat diets: a randomized trial. Ann Intern Med. 2014 Sep 2;161(5):309-18. doi: 10.7326/M14-0180. PubMed 25178568 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00609271
Lead sponsor
Tulane University Health Sciences Center
Responsible party
Lydia A. Bazzano (Associate Professor Epidemiology, Tulane University Health Sciences Center) — Principal investigator
First posted
Feb 7, 2008
Start date
Jan 2008
Primary completion
Jan 2011
Completion
Jan 2012
Results posted
Nov 19, 2018
Last update
Nov 19, 2018

Study contacts

Lydia A Bazzano, MD, PhD
principal investigator · Tulane University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cardiovascular Diseases→

Other studies from this sponsor

Tulane University Health Sciences Center

Start the discussion