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NCT00937638 · ClinicalTrials.gov registry record · NA
Beef in an Optimal Lean Diet (BOLD) Effects on Metabolic Syndrome
A NA study, sponsored by Penn State University.
- Completed
- Registry status
- NA
- Development phase
- 63
- Enrollment target
NCT00937638 is a NA study that has completed, run by Penn State University. The registered enrollment target is 63 participants.
The verdict
NCT00937638, a NA study, has completed, sponsored by Penn State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
Study Summary
The proposed research will provide important information about the role of 2 intervention diets that provide different amounts of lean beef and meet current nutrient recommendations for the treatment of Metabolic Syndrome (MetSyn), a chronic disease that is still increasing in prevalence at alarming rates. The experimental and diet designs will enable us to evaluate lifestyle interventions for MetSyn for persons who maintain weight, lose weight and maintain their weight loss, as is currently recommended in clinical practice. Importantly, the investigators will compare a diet high in lean beef (5 oz/day) which is compositionally similar (i.e., energy and nutrients) to the modified-DASH diet, a low beef diet which has become the Gold Standard for the management of cardiovascular disease (CVD) risk factors, including MetSyn. In addition, the investigators also will evaluate a moderate-high protein diet (BOLD+) that is higher in total protein (from mixed sources including lean beef, 7oz/day) than the BOLD diet, on CVD risk factors in persons with MetSyn. A follow-up study was conducted to assess dietary compliance in a sub-sample of the population at 12-months; participants were not informed of this end-point and additional consent was obtained. Hypotheses: 1. Healthful isocaloric diets that include lean beef as the primary source of protein (BOLD diet) with average (18%; BOLD) or moderate-high (28%; BOLD+) total protein intake will show similar or greater reductions in CVD risk, respectively when compared to a modified-DASH diet. 2. A healthful weight-loss diet, including lean beef as the primary source of protein in a high-moderate protein diet (BOLD+ diet), plus regular exercise (BOLD+ + ex) will reduce body weight equal to that of a BOLD + ex and DASH + ex intervention, but may improve CV risk factors (such as BP and TG), and therefore reduce the prevalence of MetSyn more than a BOLD + ex and DASH + ex intervention. 3. The BOLD diet will be more effective than the
Interventions
- DIETARY_SUPPLEMENT BOLD Diet
- DIETARY_SUPPLEMENT BOLD-X Diet
- DIETARY_SUPPLEMENT Modified DASH Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2009-02 |
| Est. Completion | 2012-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00937638
The ClinicalTrials.gov registry entry for NCT00937638 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Penn State University, which has 219 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which BOLD Diet is the first listed.
NCT00937638 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00937638 about?
NCT00937638 is a clinical study titled "Beef in an Optimal Lean Diet (BOLD) Effects on Metabolic Syndrome". The proposed research will provide important information about the role of 2 intervention diets that provide different amounts of lean beef and meet current nutrient recommendations for the treatment of Metabolic Syndrome (MetSyn), a chronic disease that is still increasing in prevalence at alarming...
What is the current status of trial NCT00937638?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2009-02. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00937638?
The interventions under investigation include: BOLD Diet (DIETARY_SUPPLEMENT), BOLD-X Diet (DIETARY_SUPPLEMENT), Modified DASH Diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00937638?
This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
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