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NCT00609271 · ClinicalTrials.gov registry record · NA
Study of Macronutrients and Heart Disease Risk
A NA study, sponsored by Tulane University Health Sciences Center.
- Completed
- Registry status
- NA
- Development phase
- 148
- Enrollment target
NCT00609271: Completed NA study, sponsored by Tulane University Health Sciences Center.
NCT00609271 is a NA study that has completed, run by Tulane University Health Sciences Center. The registered enrollment target is 148 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00609271, a NA study, has completed, sponsored by Tulane University Health Sciences Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 148 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- BEHAVIORAL low fat diet
- BEHAVIORAL low carbohydrate diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2008-01 |
| Est. Completion | 2012-01 |
| Phase | NA |
What the finished NCT00609271 record still lists
NCT00609271 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which low fat diet is the first listed.
NCT00609271 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00609271 about?
NCT00609271 is a clinical study titled "Study of Macronutrients and Heart Disease Risk". 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, lepti...
What is the current status of trial NCT00609271?
This trial is currently completed. It is a NA study. The enrollment target is 148 participants. The study started on 2008-01. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00609271?
The interventions under investigation include: low fat diet (BEHAVIORAL), low carbohydrate diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT00609271?
This trial is sponsored by Tulane University Health Sciences Center, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00609271's enrollment target sits among peer trials
148 702nd of 2000 higher than 1,298 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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