Effects of a Test Formula Milk Powder Combined With a Physical Activity Program on Mobility in Healthy Aging Subjects With Joint Discomfort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change from baseline in muscle extension isokinetic strength and 4 min speed step
研究概览
简要总结
Bone and muscle losses occur during ageing leading to increased risk of osteoporosis (there are more than 200 million people affected by osteoporosis worldwide), sarcopenia, loss of functionality and mobility. From around 45-50 years onwards, there is a progressive loss of muscle mass and strength (sarcopenia). This is partially due to an impairment of muscle protein synthesis in response to dietary proteins. Insufficient dietary protein may contribute to age-related loss of lean body mass (LBM) and strength which ultimately affects body movement.
Key ingredients in selected investigational product are:Milk proteins, Calcium, Vitamin D, Vitamin C, Glucosamine Sulfate, Zinc. They have effects to improve physical mobility and functionality. The investigators expect improved effects of a nutritional intervention combined with a physical activity program on mobility in healthy aging subjects with joint discomfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Target 45-65 y old
- •Suffering from (knee) pain. VAS on pain assessment <= 4 on a range 0 to 10
- •20<BMI<28
- •Time since menopause above 2y
- •iPAQ (International Physical Activity Questionnaire) score <600
排除标准
- •OA diagnosed
- •Medicine treatment
- •Chronic pain killers treatment for more than 7 consecutive days with a washout period of 2 weeks between 2 periods of treatment
- •Under corticoid, hormone (adrenal, thyroid) treatment
- •Traditional herbal medicine: in particular with claims on strengthening tendons and bones. This point will be included in FFQ (see annex) and evaluate.
- •Subjects with chronic tablets supplementation ( calcium or drinking milk over 5 day wk-1 will be excluded, vitamin D, GS, or any with effect on bone and joints ) (set up a FFQ to specially investigate intakes of calcium tablets, milk and animal foods)
- •Pregnancy
- •Subject with knee/joint surgery/replacement and CLA (Cross Ligament) injury
- •History of relevant digestive disease, organic disease of heart, liver or kidney, severe function disorder of liver or kidney, metabolic/endocrine , neurological disease (e.g., Parkinson disease, stroke) with residual impairment, vertigo
- •Unable to carry out functional tests and questionnaires correctly (KOOS, physical activity)
- •Lower or upper extremity surgery or fracture in the last 3 months
- •Currently participating or having participated in another clinical trial in the three previous months
结局指标
主要结局
Change from baseline in muscle extension isokinetic strength and 4 min speed step
时间窗: Baseline and visit 7
Change from baseline and muscle(quadriceps)extension isokinetic strength (peak torque) and 4 min speed step will be measured as the change of musculoskeletal functionality and mobitliy.
次要结局
未报告次要终点