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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 is a NA study that has completed, run by Tulane University Health Sciences Center. The registered enrollment target is 148 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00609271
The ClinicalTrials.gov registry entry for NCT00609271 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tulane University Health Sciences Center, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which low fat diet is the first listed.
NCT00609271 reports 0 study locations.
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.
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