Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2025-12-29 @ 6:21 AM
Study NCT ID:
NCT01725958
Status:
COMPLETED
Last Update Posted:
2014-10-29
First Post:
2012-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Nutritional Supplement Combination on Body Weight Management
Sponsor:
Pharmanex
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: