Phase 4
N=60
The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet
Body Weight Changes
Bottom Line
View on ClinicalTrials.gov: NCT00138645 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2009
Primary outcome: Primary: Body Weight Loss (kg and Percent) at Months 3 and 6
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- MicroDiet (Behavioral); Healthy Diet (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- May 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Weight Loss (kg and Percent) at Months 3 and 6 |
— | — |
| PRIMARY Percent Change in Body Weight (Completers). |
7.3; 7.0 | — |
| SECONDARY Change in Body Composition at Months 3 and 6 |
— | — |
| SECONDARY Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6 |
— | — |
| SECONDARY Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6 |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female gender; of all ethnic backgrounds.
- Healthy person who has not been diagnosed with diabetes, cardiovascular illness, renal, hepatic or other chronic diseases
- > 17 years and 65 years and 126); persons with impaired glucose tolerance (FBS 100-125) may be admitted to the study.
- Use of tobacco products
- Depression or mental illness requiring treatment or medication within the last six months
- For women, pregnancy, breast feeding, postpartum 1.5) or liver function (liver enzymes > 3 times the upper limits of normal)
Data sourced from ClinicalTrials.gov (NCT00138645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.