The Impact of Collagen Peptide Supplementation on Joint Pain and Fat-Free Mass in Lifelong Athletes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Joint Health
研究概览
简要总结
The aim of the current research is to evaluate the effects of 6 and 9 months of Solugel® supplementation on joint mobility, comfort, performance, body composition and related biomarkers of joint and bone health in older life-long athletes and physically active people. Doses of zero, 10, and 20 g per day for 6 or 9 months will be administered to determine, if any, is most effective at improving the previously mentioned outcomes.
详细描述
2.0 Objectives*
2.1 The aim of the current research is to evaluate the effects of 6 and 9 months of Solugel® supplementation on joint mobility, comfort, performance, body composition and related biomarkers of joint and bone health in older life-long athletes and physically active people. Doses of zero, 10, and 20g per day for 6 or 9 months will be administered to determine, if any, is most effective at improving the previously mentioned outcomes
2.2 We hypothesize that Solugel® at 10g and 20g will be more effective than the placebo supplement at all outcome measures. We also hypothesize that 20g will be more effective than 10g.
3.0 Background*
3.1 Very active individuals may describe joint discomfort as one negative aspect limiting their healthy lifestyles. Indeed, competitive swimmers (Wanivenhaus et al. Sports Health. 2012; 4:246-51) and those who partake in significant outdoor activity report substantial joint discomfort (Mranda et al. Osteoarthr Cartil. 2002; 10:623-30). This joint discomfort may be related to osteoarthritis (OA), a degenerative joint disease, presenting with focal and progressive loss of hyaline cartilage of joints with joint space narrowing. Current treatment for OA and joint pain include injectable corticosteroids and non-steroidal anti-inflammatory drugs. These modes of treatment are effective for reducing pain, however, they are not without serious long-term adverse effects including joint infection, nerve damage, possible tendon weakening, dyspepsia, ulcers, bleeding and other gastrointestinal complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This was a double blind study, in which investigators were not unblinded until all primary data end points were statistically analyzed. One person who was not involved in the study maintained the key until investigators were ready to be unblinded.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 40-65 year.
- •Perform greater than 4 hours per week of planned physical activity for the last 15 years.
- •Report having periodic but sustained joint and/or musculoskeletal pain.
- •Live in or near Tallahassee, FL.
排除标准
- •Currently consuming collagen supplements (a 4 week washout period from the excluding supplement may be performed for the participant to be included).
- •Currently using prescription pain medications (and cannot discontinue use during enrollment).
- •Cortisone shot within the past 30 days (30 day washout period required).
- •Diagnosis of arthritis in the joints of interest (knee, hip, or shoulder joint).
- •Diagnosis of autoimmune disorder.
- •Initiation of hormone replacement therapy within the past 12 months.
- •Uncontrolled medicated hypertension.
- •Diagnosed kidney dysfunction.
- •Allergies to milk or animal products.
- •Surgery within the past 12 months.
结局指标
主要结局
Joint Health
时间窗: 9 months
Knee Injury and Osteoarthritis Outcome Score (KOOS). Scores are from 0 to 100, with a score of 100 being the best score, and a score of 0 being the lowest.
次要结局
未报告次要终点
研究者
Michael J. Ormsbee
Professor
Florida State University