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NCT00138645 · ClinicalTrials.gov registry record · Phase 4
The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet
A Phase 4 study of Body Weight Changes, sponsored by Pennington Biomedical Research Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT00138645 is a Phase 4 study of Body Weight Changes that has completed, run by Pennington Biomedical Research Center. The registered enrollment target is 60 participants, roughly in line with the 66-participant average among 11 other Body Weight Changes trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT00138645, a Phase 4 study of Body Weight Changes, has completed, sponsored by Pennington Biomedical Research Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
It is hypothesized that the use of a partial supplement diet, which includes the use of meal replacements, will result in significantly greater weight loss after three and six months compared to an isocaloric diet that does not include supplements. It is also hypothesized that the partial supplement diet will result in larger improvements in body composition, disease biomarkers, and health parameters (blood pressure, lipids) compared to the non-supplement diet. Finally, it is hypothesized that subjective ratings of satiety will be significantly higher, and ratings of hunger lower, in the group consuming a partial supplement diet.
Conditions Studied
Interventions
- BEHAVIORAL MicroDiet
- BEHAVIORAL Healthy Diet
Study Locations (1)
Louisiana
- Pennington Biomedical Research Center - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2005-04 |
| Est. Completion | 2006-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00138645
The ClinicalTrials.gov registry entry for NCT00138645 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 66-participant average among 11 other Body Weight Changes trials with a reported enrollment target. The listed sponsor is Pennington Biomedical Research Center, which has 258 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Body Weight Changes appearing as the primary indexed condition, and to 2 interventions - of which MicroDiet is the first listed.
NCT00138645 reports 1 study location spanning 1 distinct geographic area - top geographies include Louisiana.
Frequently Asked Questions
What is clinical trial NCT00138645 about?
NCT00138645 is a clinical study titled "The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet". It is hypothesized that the use of a partial supplement diet, which includes the use of meal replacements, will result in significantly greater weight loss after three and six months compared to an isocaloric diet that does not include supplements. It is also hypothesized that the partial supplement...
What is the current status of trial NCT00138645?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2005-04. Estimated completion is 2006-05.
What conditions does trial NCT00138645 study?
This clinical trial studies the following conditions: Body Weight Changes.
What interventions are being tested in trial NCT00138645?
The interventions under investigation include: MicroDiet (BEHAVIORAL), Healthy Diet (BEHAVIORAL).
Who is sponsoring clinical trial NCT00138645?
This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00138645 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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