The Efficacy of Nutrilite All-plant Protein Booster to Improve Sarcopenia and Osteoarthritis in Middle-aged and Elderly People
NCT Number: NCT06499012
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Osteoarthritis|Sarcopenia
Interventions: DIETARY_SUPPLEMENT: All-plant Protein Booster Product Group|DIETARY_SUPPLEMENT: Placebo Group
Sponsor: Amway (China) R&D Center
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-10-15
Completion Date: 2025-12-31
Locations: Jinhua Wenrong Hospital, Jinhua, Zhejiang, China

Summary:
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

Primary Outcome Measures: Change of SPPB Score from baseline, 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)., baseline day 0, week 12|Change of WOMAC 3.1 index from baseline, 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., baseline day 0, week 12
Secondary Outcome Measures: Change of bone density measured by DXA Bone Densitometer from baseline, Change of bone density measured by DXA Bone Densitometer from baseline to week 12, baseline day 0, week 12|Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline, Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline to week 12, baseline day 0, week 12|Improvement of Quality of Life by WHOQOL BREF, WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales., baseline day 0, week 12|Improvement of Quality of Life by SF-36, The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that comprises 36 questions that cover eight domains of health., baseline day 0, week 12|Improvement of Quality of Life by Chalder Fatigue Scale (CFQ 11), Change of Chalder Fatigue Scale (CFQ 11), with range from 0 to 11 (the bigger the score, the more fatigue a person feels), from baseline to week 12. The Chalder fatigue scale (CFQ 11) is a questionnaire created by the research team of Trudie Chalder at King's College London to measure the severity of tiredness in fatiguing illnesses., baseline day 0, week 12|Change of SFQ from baseline, The change of frequency of sports activity by SFQ (Sports Frequency Questionnaire) from baseline to week 12, baseline day 0, week 12