A Randomized, Double-blind Clinical Study of the Efficacy of Nutrilite All-plant Protein Booster to Improve Sarcopenia and Osteoarthritis in Middle-aged and Elderly People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 2
- 主要终点
- Change of SPPB Score from baseline
研究概览
简要总结
The goal of this clinical trial is to learn whether Amway Nutrilite All-plant protein booster prototype product (test product) will improve sarcopenia (SA) and osteoarthritis (OA) in middle-aged and elderly people. It will also learn about the improvement of Quality of life (QoL) in them. The main questions it aims to answer are:
- Does the test product will improve the SA in terms of Short Physical Performance Battery (SPPB score) after 12 weeks' intervention?
- Does the test product will improve the OA in terms of Western Ontario and McMaster Universities Arthritis (WOMAC Index) after 12 weeks' intervention?
Researchers will compare Amway All-plant protein booster prototype product to a placebo (a look-alike substance that contains no similar active nutrient ingredients) to see if the test product works to improve SA and OA.
Participants will:
- Take the test product or a placebo 2 spoons (15g) twice per day for 12 weeks
- Visit the site on the baseline day and the 84th day (end day of 12 weeks) for checkups and tests
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
- •Be age 50 to 70 years, female and male
- •Participants will be required to have mild to moderately OA & SA evaluated by Kellgren-Lawrence I-II and SARC-Cal, respectively
- •Participants need to be competent i.e., able to understand what is to take place and able to provide a free decision on agreeing to the activity/taking part on the study on this
- •Participants must be able to read and understand study instructions and any other relevant study documents
- •Willing to following the lifestyle restrictions as detailed in the Information Sheet for study
- •Will to give written informed consent
排除标准
- •Have a fever currently, or for 24 hours before enrollment
- •Currently participating in another clinical study
- •Have taken other protein powder products and dietary supplements or medicines containing peptides or hyaluronic acid within the past 6 months (subject to product instructions)
- •Individuals receiving medical treatment that, in the opinion of the Principal Investigator or Study Physician, may interfere with test results
- •The participant is an employee of Amway or SPRIM Medical
- •Subject who is in the treatment of gastrointestinal diseases
- •Subject with abnormal liver function tests (alanine aminotransferase and aspartate aminotransferase), kidney function tests (blood urea nitrogen and creatinine), blood routine, urine routine, fecal occult blood test, or electrocardiogram.
- •Subjects have any of the following medical history or have been clinically examined to have the following diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases
结局指标
主要结局
Change of SPPB Score from baseline
时间窗: baseline day 0, week 12
The SPPB (Short Physical Performance Battery) test is a group of measures that combines the results of the gait speed, chair stand and balance tests (Guralnik et al., 2000). lt has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance).
Change of WOMAC 3.1 index from baseline
时间窗: baseline day 0, week 12
The WOMAC (Western Ontario and McMaster Universities Arthritis) Index was created to assess pain, stiffness, and physical function in patients with hip and / or knee osteoarthritis (OA). The WOMAC 3.1 consists of 24 items divided into 3 subscales. The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A total WOMAC score is created by summing the items for all three subscales. (0-96), higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
次要结局
- Improvement of Quality of Life by Chalder Fatigue Scale (CFQ 11)(baseline day 0, week 12)
- Change of SFQ from baseline(baseline day 0, week 12)
- Change of bone density measured by DXA Bone Densitometer from baseline(baseline day 0, week 12)
- Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline(baseline day 0, week 12)
- Improvement of Quality of Life by WHOQOL BREF(baseline day 0, week 12)
- Improvement of Quality of Life by SF-36(baseline day 0, week 12)