Effects of a Nutritional Supplement Combination on Body Weight Management
|ClinicalTrials.gov Identifier: NCT01725958|
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : October 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Safety/Effacy||Dietary Supplement: Nutritional supplement and protein shakes||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
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
- -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 [ Time Frame: 90 days ]
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725958
|United States, Utah|
|Aspen Clinical Research|
|Orem, Utah, United States, 84058|
|Study Director:||Steve Poole, BS||Pharmanex|