CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 148 enrolled
Drug / intervention
low carbohydrate diet +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00609271
NCT00609271N/ACompleted

Macronutrient Composition of Diet and Risk Factors for Cardiovascular Disease

Tulane University Health Sciences Center·interventional·Posted Feb 7, 2008·Updated Nov 19, 2018

In Brief

A clinical study evaluating low carbohydrate diet and low fat diet for Obesity and 3 related conditions. Completed, enrolled 148 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 7, 2008
Enrollment StartJan 1, 2008
Primary CompletionJan 1, 2011
Study CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 18.4 years ago

Interventions

low carbohydrate dietbehavioral

\<40 grams carbohydrate/day

low fat dietbehavioral

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