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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Functional Capacity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Functional Capacity
时间窗: 14 weeks
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.
次要结局
- Weight loss and body composition(14 weeks)
- Blood and Hormones(14 Weeks)
- Psychosocial(14 Weeks)