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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: Completed Phase 4 study of Body Weight Changes, sponsored by Pennington Biomedical Research Center.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 60 participants
Start Date 2005-04
Est. Completion 2006-05
Phase Phase 4

What the finished NCT00138645 record still lists

NCT00138645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 66-participant average among 11 other Body Weight Changes trials with a reported enrollment target.

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 a single indexed study location in 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.

Similar trials for Body Weight Changes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00138645's enrollment target sits among peer trials

60 4th of 11 higher than 6 of 11 other Body Weight Changes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Body Weight Changes 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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Source: ClinicalTrials.gov NCT00138645, the US trial registry maintained by the National Library of Medicine. NCT00138645 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.