To Investigate Effects of Amway Bundle Combination of Products on Osteoarthritis & Sarcopenia

Sponsor

Amway (China) R&D Center (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05872360

Collaborator

(none)

240

Enrollment

Locations

Arms

8.9

Anticipated Duration (Months)

120

Patients Per Site

13.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis Sarcopenia	Dietary Supplement: Bundle Group 1 with Nutrilite Lifestyle Dietary Supplement: Bundle Group 2 without Nutrilite Lifestyle Dietary Supplement: Control Group 1 Dietary Supplement: Control Group 2 with Nutrilite Lifestyle	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

A Randomized, Double-blind Controlled Trial to Investigate Effects of Amway Bundle Combination of Products on Osteoarthritis & Sarcopenia

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bundle Group 1 with Nutrilite Lifestyle Amway All-plant protein booster: 450g/bottle, containing the following active ingredients and with the guideline of Nutrilite Lifestyle: All-plant protein Peptide HA (hyaluronicacid) Calcium Magnesium Glucosamine Facility: EMS (electric muscle stimulation) Nutrition Guideline: Nutrilite Lifestyle	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.
Active Comparator: Bundle Group 2 without Nutrilite Lifestyle Amway All-plant protein booster: 450g/bottle, containing the following active ingredients: All-plant protein Peptide HA (hyaluronicacid) Calcium Magnesium Glucosamine Facility: EMS (electric muscle stimulation)	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.
Placebo Comparator: Control Group 1 Placebo for all-plant protein booster: 450g/bottle, containing the following ingredients: Maltodextrin	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.
Placebo Comparator: Control Group 2 with Nutrilite Lifestyle Placebo for all-plant protein booster: 450g/bottle, containing the following ingredients: Maltodextrin Nutrition Guideline: Nutrilite Lifestyle	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.

Outcome Measures

Primary Outcome Measures

Change of Short Physical Performance Battery (SPPB) score from baseline [baseline day 0, day 180]
Change of Short Physical Performance Battery (SPPB) score [0,12] from baseline to day 180

Secondary Outcome Measures

Change of WOMAC Questionnaire Scores from baseline [baseline day 0, day 90, day 180]
Change of WOMAC Questionnaire Scores from baseline to day 90 and day 180
Change of Visual Analogue Scale/Score (VAS) from baseline [baseline day 0, day 90, day 180]
Change of Visual Analogue Scale/Score (VAS), with range from 0 to 10 (the smaller the score, the better visual result), from baseline to day 90 and day 180
Change of Chalder Fatigue Scale (CFS) from baseline [baseline day 0, day 90, day 180]
Change of Chalder Fatigue Scale (CFS), FS-14, with range from 0 to 14 (the bigger the score, the more fatigue a person feels), from baseline to day 90 and day 180
Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline [baseline day 0, day 90, day 180]
Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline to day 90 and day 180
Change of Hand & Grip Strength measured by Jamar Smart Hand Dynamometer from baseline [baseline day 0, day 90, day 180]
Change of Hand & Grip Strength measured by Jamar Smart Hand Dynamometer from baseline to day 90 and day 180
Change of bone density measured by DXA Bone Densitometer from baseline [baseline day 0, day 90, day 180]
Change of bone density measured by DXA Bone Densitometer from baseline to day 90 and day 180

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Luodian Community Hospital	Shanghai	Shanghai	China
2	Shanghai Luodian Hospital	Shanghai	Shanghai	China

Sponsors and Collaborators

Amway (China) R&D Center

Investigators

Principal Investigator: Tao Wu, MD, Shanghai Fudan Univisity School of Medicine
Principal Investigator: Jianqiang Sun, MD, Shanghai Fudan Univisity School of Medicine