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
Safety assessment: 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. Efficacy Assessment: 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Aspen Clinical Research
Orem, Utah, United States
-Evaluate the changes in body composition as determined by percent body fat using the Bod Pod
Time frame: 90 Days
Evaluate the changes in body weight
* 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)
Time frame: 90 days
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