Effects of a Nutritional Supplement Combination on Body Weight Management
Title: A Phase IV, Open-label, Single-Center Study on the Effects of a Nutritional Supplement Combination on Body Weight Management over a 90-day period
Dietary Supplement: Nutritional supplement and protein shakes
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IV, Open-label, Parallel Group, Single-Center Study on the Effects of a Nutritional Supplement Combination on Body Weight Management Over a 90-day Period|
- -Evaluate the changes in body composition as determined by percent body fat using the Bod Pod [ Time Frame: 90 Days ] [ Designated as safety issue: Yes ]
- Evaluate the changes in body weight [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- Determine the safety and tolerability of a weight loss system and dietary supplements containing ingredients to promote healthy weight
- Evaluate the changes in body weight as measured by body weight and body composition changes (as determined by BMI as well as changes in body measurements-waist, hip, arm, and ankle circumferences) of a weight loss system and dietary supplements containing ingredients to promote healthy weight.
- Determine changes in substrate energy utilization
- Determine subjective measurements of hunger, appetite, feeling of well being during weight loss
- Determine changes in expansion and return of blood vessels (pulse wave analyzer)
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Dietary Supplement
-The Nutritional Supplement will be given for approximately 90 days in the form of 7 capsules and a powder to mix into liquids or foods for the first 15 days of program. Subjects will also drink a protein shake.
|Dietary Supplement: Nutritional supplement and protein shakes|
Safety will be assessed by changes in blood chemistries/hematology, and adverse events, of nutritional supplement emergent AEs (TEAEs), classified by severity grade, relatedness to the nutritional supplement.
The objectives of this study are to evaluate the efficacy (changes in body composition and measurements as well as influence on appetite and quality of life changes) of the nutritional supplement administered repeatedly throughout the study.
Study Subject Population:
Healthy adult men and women are eligible for participation upon fulfillment of the inclusion/exclusion criteria.