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

April 7, 2024 updated by: Amway (China) R&D Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Raison Healthcare Lab
      • Shanghai, Shanghai, China
        • Raison Healthcare R&D Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Short Physical Performance Battery (SPPB) score from baseline
Time Frame: baseline day 0, day 180
Change of Short Physical Performance Battery (SPPB) score [0,12] from baseline to day 180
baseline day 0, day 180

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of WOMAC Questionnaire Scores from baseline
Time Frame: baseline day 0, day 90, day 180
Change of WOMAC Questionnaire Scores from baseline to day 90 and day 180
baseline day 0, day 90, day 180
Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline
Time Frame: 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
baseline day 0, day 90, day 180
Change of Hand & Grip Strength measured by Jamar Smart Hand Dynamometer from baseline
Time Frame: 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
baseline day 0, day 90, day 180
Change of bone density measured by DXA Bone Densitometer from baseline
Time Frame: baseline day 0, day 90, day 180
Change of bone density measured by DXA Bone Densitometer from baseline to day 90 and day 180
baseline day 0, day 90, day 180
Change of Visual Analogue Scale/Score (VAS) from baseline
Time Frame: 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
baseline day 0, day 90, day 180
Change of Chalder Fatigue Scale (CFS) from baseline
Time Frame: 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
baseline day 0, day 90, day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amway (China) R&D Center

Investigators

  • Principal Investigator: Charlie Zhang, MD, SPRIM Medical

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2023

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

May 14, 2023

First Submitted That Met QC Criteria

May 14, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-SM-09-AY-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis

Clinical Trials on Bundle Group 1 with Nutrilite Lifestyle

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe