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Effects of Glucosamine and Chondroitin Supplementation in Women With Knee Osteoarthritis Participating in an Exercise and Weight Loss Program

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Diet
Exercise
Sponsored by
Texas A&M University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

- General entrance criteria included being a female with physician diagnosed OA between the ages of 18-70 years with a body mass index (BMI) > 27 kg/m2 and no recent participation in a diet or exercise program.

Exclusion Criteria:

- Subjects were not allowed to participate in this study if they: 1.) were pregnant, became pregnant, or had a desire for pregnancy; 2.) had any metabolic disorder including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; 3.) had a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease; were taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications; 4.) had taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, HMB), anabolic/catabolic hormone levels (e.g., DHEA), or weight loss supplements (e.g., thermogenics) within three months prior to the start of the study; 5.) were ingesting any anti-inflammatory products two weeks before the start of the study or additional products during the study; 6.) reported any unusual adverse events associated with this study in which the supervising physician recommended removal from the study; 7.) had significant injury or surgery to the lower extremity or spine within the last six months; 8.) did not indicate a minimal amount of perceived pain and physical function limitation on inventories used in the study; 9.) had severe arthritis that required surgery and greatly limited functionality (inability to perform lunge); or, 10.) had arthritis that required the current use of physiotherapy modalities.

Sites / Locations

  • Exercise & Sport Nutrition Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Active Supplement

Arm Description

Participants ingested 2,200 mg/day of a placebo or active dietary supplement. Participants ingested three caplets in the morning and the remaining three caplets in the evening 30-minutes before a meal for 14-weeks. The supplements were prepared in caplet form and packaged in generic bottles for double blind administration. The placebo was a starch-based placebo matched for color, texture, and taste to the active supplement.

Participants were randomly assigned to ingest in a double-blind manner caplets containing a commercially available glucosamine/chondroitin (GC) dietary supplement (Curves Joint and Connective Support™, Curves International, Waco, TX) or a suitable placebo (P). The GC supplement provided a total of 1,500 mg/d of glucosamine, 1,200 mg/d of chondroitin sulfate, 120 mg/d of niacin, 120 mg/d of sodium, 45 mg/d of zinc, 900 mg/d MSM, 300 mg/d of boswellia serrata extract, 180 mg/d of white willow bark extract, and 15 mg/d of rutin powder. Participants ingested three caplets in the morning and the remaining three caplets in the evening 30-minutes before a meal for 14-weeks.

Outcomes

Primary Outcome Measures

Functional Capacity
Perceptions of pain, knee flexibility, knee strength and endurance, upper body strength and endurance, peak aerobic capacity, and functional assessmentof balance using the sit to stand, step up and over, and forward lunge tests.

Secondary Outcome Measures

Weight loss and body composition
All participants were tested for changes in energy intake; anthropometrics; body composition; and resting energy expenditure to assess magnitude of weight loss in response to a higher carbohydrate and higher protein diet.
Blood and Hormones
General whole blood and serum clinical chemistries (cholesterol, triglycerides, glucose, blood urea nitrogen, creatinine, uric acid, muscle and liver enzymes) and hormones (C-Reactive Protein, IL-6, TNF-alpha, cortisol, insulin, homeostasis model of insulin sensitivity, and leptin).
Psychosocial
SF-36 quality of life indices

Full Information

First Posted
January 5, 2011
Last Updated
January 5, 2011
Sponsor
Texas A&M University
Collaborators
Baylor University, Curves International
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1. Study Identification

Unique Protocol Identification Number
NCT01271218
Brief Title
Effects of Glucosamine and Chondroitin Supplementation in Women With Knee Osteoarthritis Participating in an Exercise and Weight Loss Program
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Texas A&M University
Collaborators
Baylor University, Curves International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants ingested 2,200 mg/day of a placebo or active dietary supplement. Participants ingested three caplets in the morning and the remaining three caplets in the evening 30-minutes before a meal for 14-weeks. The supplements were prepared in caplet form and packaged in generic bottles for double blind administration. The placebo was a starch-based placebo matched for color, texture, and taste to the active supplement.
Arm Title
Active Supplement
Arm Type
Active Comparator
Arm Description
Participants were randomly assigned to ingest in a double-blind manner caplets containing a commercially available glucosamine/chondroitin (GC) dietary supplement (Curves Joint and Connective Support™, Curves International, Waco, TX) or a suitable placebo (P). The GC supplement provided a total of 1,500 mg/d of glucosamine, 1,200 mg/d of chondroitin sulfate, 120 mg/d of niacin, 120 mg/d of sodium, 45 mg/d of zinc, 900 mg/d MSM, 300 mg/d of boswellia serrata extract, 180 mg/d of white willow bark extract, and 15 mg/d of rutin powder. Participants ingested three caplets in the morning and the remaining three caplets in the evening 30-minutes before a meal for 14-weeks.
Intervention Type
Other
Intervention Name(s)
Diet
Other Intervention Name(s)
Curves® weight loss program (Curves International, Waco, TX).
Intervention Description
Participants followed isoenergetic low fat diets with higher protein (HP) or higher carbohydrate (HC) macronutrient content. Participants consumed 1,200 kcals/d for 1-week (Phase I) and 1,600 kcals/d for 9-weeks (Phase II) during a 10-week weight loss period. Participants in the HC diet consumed a diet containing 55% carbohydrate, 15% protein, and 30% fat. Subjects in the HP group consumed a diet containing 7% carbohydrate, 63% protein, and 30% fat during Phase I of the diet and 15% carbohydrate, 55% protein, and 30% fat during Phase II of the diet. The final 4-weeks of the diet (Phase III) served as a weight maintenance period in which participants consumed 2,600 kcals•d-1 consisting of 55% carbohydrate, 15% protein, and 30% fat and were instructed to follow their respective Phase I diet (1,200 kcals/d) for 2-days only if they gained 1.35 kg (3 lbs).
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Curves exercise program.
Intervention Description
All subjects participated in a supervised exercise program three days per week for 14-weeks. Each circuit-style workout consisted of 14 exercises (e.g. elbow flexion/extension, knee flexion/extension, shoulder press/lat pull, hip abductor/adductor, chest press/seated row, horizontal leg press, squat, abdominal crunch/back extension, pec deck, oblique, shoulder shrug/dip, hip extension, side bends and stepping). Participants performed as many repetitions in a 30-s time period. In a continuous, interval fashion, participants performed floor-based callisthenic (e.g. running/skipping in place, arm circles, etc.) exercises on recovery pads for a 30-s time period after each resistance exercise in an effort to maintain a consistent exercise heart rate that corresponded to 60% to 80% of their maximum heart rate.
Primary Outcome Measure Information:
Title
Functional Capacity
Description
Perceptions of pain, knee flexibility, knee strength and endurance, upper body strength and endurance, peak aerobic capacity, and functional assessmentof balance using the sit to stand, step up and over, and forward lunge tests.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Weight loss and body composition
Description
All participants were tested for changes in energy intake; anthropometrics; body composition; and resting energy expenditure to assess magnitude of weight loss in response to a higher carbohydrate and higher protein diet.
Time Frame
14 weeks
Title
Blood and Hormones
Description
General whole blood and serum clinical chemistries (cholesterol, triglycerides, glucose, blood urea nitrogen, creatinine, uric acid, muscle and liver enzymes) and hormones (C-Reactive Protein, IL-6, TNF-alpha, cortisol, insulin, homeostasis model of insulin sensitivity, and leptin).
Time Frame
14 Weeks
Title
Psychosocial
Description
SF-36 quality of life indices
Time Frame
14 Weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - General entrance criteria included being a female with physician diagnosed OA between the ages of 18-70 years with a body mass index (BMI) > 27 kg/m2 and no recent participation in a diet or exercise program. Exclusion Criteria: - Subjects were not allowed to participate in this study if they: 1.) were pregnant, became pregnant, or had a desire for pregnancy; 2.) had any metabolic disorder including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; 3.) had a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease; were taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications; 4.) had taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, HMB), anabolic/catabolic hormone levels (e.g., DHEA), or weight loss supplements (e.g., thermogenics) within three months prior to the start of the study; 5.) were ingesting any anti-inflammatory products two weeks before the start of the study or additional products during the study; 6.) reported any unusual adverse events associated with this study in which the supervising physician recommended removal from the study; 7.) had significant injury or surgery to the lower extremity or spine within the last six months; 8.) did not indicate a minimal amount of perceived pain and physical function limitation on inventories used in the study; 9.) had severe arthritis that required surgery and greatly limited functionality (inability to perform lunge); or, 10.) had arthritis that required the current use of physiotherapy modalities.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B Kreider, PhD
Organizational Affiliation
Texas A&M University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Exercise & Sport Nutrition Lab
City
College Station
State/Province
Texas
ZIP/Postal Code
78843
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21689421
Citation
Magrans-Courtney T, Wilborn C, Rasmussen C, Ferreira M, Greenwood L, Campbell B, Kerksick CM, Nassar E, Li R, Iosia M, Cooke M, Dugan K, Willoughby D, Soliah L, Kreider RB. Effects of diet type and supplementation of glucosamine, chondroitin, and MSM on body composition, functional status, and markers of health in women with knee osteoarthritis initiating a resistance-based exercise and weight loss program. J Int Soc Sports Nutr. 2011 Jun 20;8(1):8. doi: 10.1186/1550-2783-8-8.
Results Reference
derived
Links:
URL
http://esnl.tamu.edu
Description
Exercise & Sport Nutrition Lab

Learn more about this trial

Effects of Glucosamine and Chondroitin Supplementation in Women With Knee Osteoarthritis Participating in an Exercise and Weight Loss Program

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