A Randomized, Double-blind Controlled Trial to Investigate Effects of Amway Bundle Combination of Products on Osteoarthritis & Sarcopenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Change of Short Physical Performance Battery (SPPB) score from baseline
研究概览
简要总结
The goal of this interventional study is to evaluate the effects of bundle combination of Amway All-plant protein booster with Nutrilite Lifestyle guideline and/or EMS (Electric Muscle Stimulation) device on Osteoarthritis & Sarcopenia in the middle-aged and elderly (50-70 years old) people.
240 eligible participants will be randomly assigned to 4 equal size study groups (ideally 52 for each group will complete the study) in the two study centers in Shanghai, three site visits will be made during the 6 months of study after screening test. All clinical data will be measured /captured on paper CRF(Case Report Form) and then recorded into CTMS(Clinical Trial Data Management System) for analysis and reporting. It's essential that participants should practice with the assigned guideline and device besides taking the products per day.
Researchers will compare the four groups to see if there is significant improvement of Amway study products with bundle combination of Nutrilite Lifestyle guideline and/or EMS on Osteoarthritis & Sarcopenia in the participants.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese males or females, age between 50-70;
- •SPPB scale 4 - 9, but walking 400 meters within 15 minutes;
- •Reporting <20 min/week in the past month performing regular physical activity and <125 min/week of moderate physical activity;
- •Willing to comply with all research requirements and procedures;
- •Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate.
排除标准
- •Have used any medication for OA & SA at least one month before this study.
- •Subject having done plastic surgery for OA & SA.
- •Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product.
- •Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently.
- •Have a history of any type of metabolic syndrome, including but not limited to any type of diabetes, obesity and heart disease.
- •Have a history of any disease or the presence of health condition on the study sites that the Investigator feels would interfere with the study.
- •Be taking antihistamines (> 3x/week) or anti-inflammatory (> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrolment.
- •Have any of the following conditions or factors that the investigator believes may affect the study objectives caused by medication by protein, glucosamine, calcium and magnesium or supplements to improve capability of the sports.
- •Have any allergy caused by all-plant protein and sea-food.
- •The regular exercises more than 125 minutes per week.
结局指标
主要结局
Change of Short Physical Performance Battery (SPPB) score from baseline
时间窗: baseline day 0, day 180
Change of Short Physical Performance Battery (SPPB) score \[0,12\] from baseline to day 180
次要结局
- Change of WOMAC Questionnaire Scores from baseline(baseline day 0, day 90, day 180)
- Change of Chalder Fatigue Scale (CFS) from baseline(baseline day 0, day 90, day 180)
- Change of Visual Analogue Scale/Score (VAS) from baseline(baseline day 0, day 90, day 180)
- Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline(baseline day 0, day 90, day 180)
- Change of bone density measured by DXA Bone Densitometer from baseline(baseline day 0, day 90, day 180)
- Change of Hand & Grip Strength measured by Jamar Smart Hand Dynamometer from baseline(baseline day 0, day 90, day 180)