To Investigate Effects of Amway Bundle Combination of Products on Osteoarthritis & Sarcopenia
NCT05872360 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2024-04-09
Summary
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.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Bundle Group 1 with Nutrilite Lifestyle
All-plant protein booster: 2 spoons (15g), twice per day. Calcium \& Magnesium:3 tablets one time per day. Glucosamine: 2 tablets two times per day. 20 minutes training with EMS (Electric Muscle Stimulation) per day. Practice according to Nutrilite Lifestyle Guideline per day.
- DIETARY_SUPPLEMENT
-
Bundle Group 2 without Nutrilite Lifestyle
All-plant protein booster: 2 spoons (15g), twice per day. Calcium \& Magnesium:3 tablets one time per day. Glucosamine: 2 tablets two times per day. 20 minutes training with EMS (Electric Muscle Stimulation) per day.
- DIETARY_SUPPLEMENT
-
Control Group 1
Placebo: 2 spoons (15g), twice per day. Placebo for Calcium \& Magnesium:3 tablets one time per day. Placebo for Glucosamine: 2 tablets two times per day.
- DIETARY_SUPPLEMENT
-
Control Group 2 with Nutrilite Lifestyle
Placebo: 2 spoons (15g), twice per day. Placebo for Calcium \& Magnesium:3 tablets one time per day. Placebo for Glucosamine: 2 tablets two times per day. Practice according to Nutrilite Lifestyle Guideline per day.
Sponsors & Collaborators
-
Amway (China) R&D Center
lead INDUSTRY
Principal Investigators
-
Charlie Zhang, MD · SPRIM Medical
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-05-27
- Primary Completion
- 2024-02-28
- Completion
- 2024-02-28
Countries
- China
Study Locations
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