Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT01271218
Status:
COMPLETED
Last Update Posted:
2011-01-06
First Post:
2011-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Glucosamine and Chondroitin Supplementation in Women With Knee Osteoarthritis Participating in an Exercise and Weight Loss Program
Sponsor:
Texas A&M University
Organization:
Study Overview
Official Title:
Effects of Glucosamine and Chondroitin Supplementation in Women With Knee Osteoarthritis Participating in an Exercise and Weight Loss Program: a Randomized Placebo Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2011-01
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:
Background: Exercise, weight loss, and dietary supplementation of glucosamine and chondroitin (GC) have been reported to improve functional capacity in individuals with knee osteoarthritis (OA). The purpose of this study was 1.) to determine whether women with knee OA who follow a higher protein diet observe more favorable changes in body composition and/or markers of health compared to those following a standard higher carbohydrate-based diet; and, 2.) to determine whether dietary supplementation of glucosamine and chondroitin during a weight loss and fitness program lessens symptoms of pain, improves functional capacity, and/or promotes greater health benefits in women with knee OA. It was hypothesized that both groups would experience beneficial changes in body mass, body composition, and markers of health. However, greater benefits would be observed in those following a higher protein diet while supplementing the diet with glucosamine and chondroitin.
Detailed Description:
The study was conducted as a randomized, double-blind, placebo-controlled clinical trial in a university research setting. Participants with physician diagnosed OA participated in a 14-week fitness and weight loss program that consisted of moderately hypo-energetic higher protein or higher carbohydrate diets. Participants were also randomly assigned to ingest in a double-blind and randomized manner either a placebo or a commercially available dietary supplement containing glucosamine and chondroitin. Outcome measures were assessed at 0, 10, and 14 weeks of training, dieting, and supplementation.
Study Oversight
Has Oversight DMC:
False
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?: