NCT01725958

Effects of a Nutritional Supplement Combination on Body Weight Management

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Pharmanex · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Safety/Effacy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutritional supplement and protein shakes

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2012-11-14
• Last updated: 2014-10-29

Locations

1 site across 1 country: United States