At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years
- ✓BMI 25–35 kg/m²
- ✓Generally healthy without diabetes, cardiovascular disease, renal, hepatic, or other chronic diseases
- ✓If female of childbearing potential: willing to use acceptable birth control or practice sexual abstinence for study duration
- ✕Age <18 or ≥66 years
- ✕Diabetes mellitus (fasting blood sugar >126 mg/dL); impaired glucose tolerance (FBS 100–125) is allowed
- ✕Regular use of medications other than birth control, vitamins, or hormone replacement therapy
- ✕Current tobacco use
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet
In Brief
A Phase 4 clinical trial evaluating MicroDiet and Healthy Diet for Body Weight Changes. Completed, enrolled 60 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
MicroDiet
Participants randomized to the Healthy Diet group will be prescribed a traditional food-based diet that contains the same number of kilocalories (1200/day) as the MicroDiet but will be instructed not to use meal replacements