N/A
Completed N=148
Study of Macronutrients and Heart Disease Risk
Source: ClinicalTrials.gov NCT00609271 ↗Enrolled (actual)
148
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group — -5.7; -2.6; -5.6; -2.3 kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Predicted Mean Difference in Body Weight From Baseline, by Assigned Dietary Group |
-5.7; -2.6; -5.6; -2.3; -5.3; -1.8 | — |
| PRIMARY Predicted Mean Differences in Lean Mass From Baseline, by Assigned Dietary Group |
1.6; 0.4; 1.5; 0.2; 1.3; -0.4 | — |
| PRIMARY Predicted Mean Differences in Fat Mass From Baseline, by Assigned Dietary Group |
-1.1; -0.3; -1.1; -0.1; -1.2; 0.3 | — |
| PRIMARY Predicted Mean Differences of Waist Circumference From Baseline, by Assigned Dietary Group |
-5.5; -3.5; -5.9; -4.0; -6.7; -5.0 | — |
| PRIMARY Predicted Mean Differences in Total Cholesterol Level From Baseline by Assigned Dietary Group |
-0.09; 0.03; -0.04; 0.03; 0.05; 0.03 | — |
| PRIMARY Predicted Mean Differences in LDL Cholesterol Level From Baseline, by Assigned Dietary Group |
-0.02; 0.05; -0.04; 0.02; -0.08; -0.05 | — |
| PRIMARY Predicted Mean Differences in HDL Cholesterol From Baseline, by Assigned Dietary Group |
0.03; -0.03; 0.10; -0.00; 0.24; 0.06 | — |
| PRIMARY Predicted Mean Differences in Total-HDL Cholesterol Ratio From Baseline, by Assigned Dietary Group |
-0.13; 0.13; -0.25; 0.07; -0.49; -0.05 | — |
| PRIMARY Predicted Mean Differences in Triglycerides From Baseline, by Assigned Dietary Group |
-0.21; 0.03; -0.22; -0.01; -0.23; -0.07 | — |
| PRIMARY Predicted Mean Differences in Systolic Blood Pressure From Baseline, by Assigned Dietary Group |
-4.2; -2.6; -2.9; -2.2; -0.2; -1.3 | — |
| PRIMARY Predicted Mean Difference in Diastolic Blood Pressure, by Assigned Dietary Group |
-2.3; -0.9; -1.7; -0.5; -0.5; 0.2 | — |
| PRIMARY Predicted Mean Difference in Plasma Glucose Level, by Assigned Dietary Group |
-0.05; -0.10; 0.03; -0.10; 0.02; -0.10 | — |
| PRIMARY Predicted Mean Differences in Serum Insulin Level From Baseline, by Assigned Dietary Group |
-25.0; -18.8; -21.5; -20.8; -13.9; -24.3 | — |
| PRIMARY Predicted Mean Differences in C-reactive Protein Level From Baseline, by Assigned Dietary Group |
-4.8; 5.7; -4.8; 6.7; -6.7; 8.6 | — |
| PRIMARY Predicted Mean Differences in Serum Creatinine Level From Baseline, by Assigned Dietary Group |
-0.1; 1.8; -3.1; -1.7; -9.2; -8.5 | — |
| PRIMARY Predicted Mean Differences of 10-y Framingham Risk Score From Baseline, by Assigned Dietary Group |
-0.5; 0.4; -0.7; 0.4; -1.0; 0.4 | — |
Eligibility Criteria
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
- 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
Data sourced from ClinicalTrials.gov (NCT00609271). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.