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

Primary Purpose

Osteoarthritis, Sarcopenia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bundle Group 1 with Nutrilite Lifestyle
Bundle Group 2 without Nutrilite Lifestyle
Control Group 1
Control Group 2 with Nutrilite Lifestyle
Sponsored by
Amway (China) R&D Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring Amway, Nutrilite Lifestyle, EMS (Electric Muscle Stimulation)

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Raison Healthcare LabRecruiting
  • Raison Healthcare R&D CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Bundle Group 1 with Nutrilite Lifestyle

Bundle Group 2 without Nutrilite Lifestyle

Control Group 1

Control Group 2 with Nutrilite Lifestyle

Arm Description

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

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)

Placebo for all-plant protein booster: 450g/bottle, containing the following ingredients: Maltodextrin

Placebo for all-plant protein booster: 450g/bottle, containing the following ingredients: Maltodextrin Nutrition Guideline: Nutrilite Lifestyle

Outcomes

Primary Outcome Measures

Change of Short Physical Performance Battery (SPPB) score from baseline
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
Change of WOMAC Questionnaire Scores from baseline to day 90 and day 180
Change of Visual Analogue Scale/Score (VAS) from baseline
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
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
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
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
Change of bone density measured by DXA Bone Densitometer from baseline to day 90 and day 180

Full Information

First Posted
May 14, 2023
Last Updated
June 26, 2023
Sponsor
Amway (China) R&D Center
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1. Study Identification

Unique Protocol Identification Number
NCT05872360
Brief Title
To Investigate Effects of Amway Bundle Combination of Products on Osteoarthritis & Sarcopenia
Official Title
A Randomized, Double-blind Controlled Trial to Investigate Effects of Amway Bundle Combination of Products on Osteoarthritis & Sarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amway (China) R&D Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Sarcopenia
Keywords
Amway, Nutrilite Lifestyle, EMS (Electric Muscle Stimulation)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bundle Group 1 with Nutrilite Lifestyle
Arm Type
Active Comparator
Arm Description
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
Arm Title
Bundle Group 2 without Nutrilite Lifestyle
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Control Group 1
Arm Type
Placebo Comparator
Arm Description
Placebo for all-plant protein booster: 450g/bottle, containing the following ingredients: Maltodextrin
Arm Title
Control Group 2 with Nutrilite Lifestyle
Arm Type
Placebo Comparator
Arm Description
Placebo for all-plant protein booster: 450g/bottle, containing the following ingredients: Maltodextrin Nutrition Guideline: Nutrilite Lifestyle
Intervention Type
Dietary Supplement
Intervention Name(s)
Bundle Group 1 with Nutrilite Lifestyle
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bundle Group 2 without Nutrilite Lifestyle
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Group 1
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control Group 2 with Nutrilite Lifestyle
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Short Physical Performance Battery (SPPB) score from baseline
Description
Change of Short Physical Performance Battery (SPPB) score [0,12] from baseline to day 180
Time Frame
baseline day 0, day 180
Secondary Outcome Measure Information:
Title
Change of WOMAC Questionnaire Scores from baseline
Description
Change of WOMAC Questionnaire Scores from baseline to day 90 and day 180
Time Frame
baseline day 0, day 90, day 180
Title
Change of Visual Analogue Scale/Score (VAS) from baseline
Description
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
Time Frame
baseline day 0, day 90, day 180
Title
Change of Chalder Fatigue Scale (CFS) from baseline
Description
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
Time Frame
baseline day 0, day 90, day 180
Title
Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline
Description
Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline to day 90 and day 180
Time Frame
baseline day 0, day 90, day 180
Title
Change of Hand & Grip Strength measured by Jamar Smart Hand Dynamometer from baseline
Description
Change of Hand & Grip Strength measured by Jamar Smart Hand Dynamometer from baseline to day 90 and day 180
Time Frame
baseline day 0, day 90, day 180
Title
Change of bone density measured by DXA Bone Densitometer from baseline
Description
Change of bone density measured by DXA Bone Densitometer from baseline to day 90 and day 180
Time Frame
baseline day 0, day 90, day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlie Zhang, MD
Phone
+8613901981272
Email
charlie.zhang@sprimmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Wu, MD
Organizational Affiliation
Shanghai Fudan Univisity School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianqiang Sun, MD
Organizational Affiliation
Shanghai Fudan Univisity School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raison Healthcare Lab
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlie Zhang, MD
Phone
+8613901981272
Email
charlie.zhang@sprimmedical.com
Facility Name
Raison Healthcare R&D Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raison H Lab, MD
Phone
+8613901981272
Email
charlie.zhang@sprimmedical.com

12. IPD Sharing Statement

Plan to Share IPD
No
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To Investigate Effects of Amway Bundle Combination of Products on Osteoarthritis & Sarcopenia

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