The Efficacy of Nutrilite All-plant Protein Booster to Improve Sarcopenia and Osteoarthritis in Middle-aged and Elderly People

NCT ID: NCT06499012

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-08
• Study Completion Date: 2025-10-02

Brief 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

Conditions

Osteoarthritis; Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

All-plant Protein Booster Product Group

Containing ingredients: Soy protein Isolate, Soybean peptide, wheat protein, pea protein, Pea peptide, Aloe Vera powder, Sweetener (Maltitol) Anti-caking (Silicon Dioxide) Thickener (guar gum, arabic gum)

Group Type: ACTIVE_COMPARATOR

All-plant Protein Booster Product Group

Intervention Type: DIETARY_SUPPLEMENT

Participants in this arm will take 2 spoons (15g) twice per day for 12 weeks

Placebo Group

Containing ingredients: Aloe Vera powder, Sweetener (Maltitol) Anti-caking (Silicon Dioxide) Thickener (guar gum, arabic gum)

Group Type: PLACEBO_COMPARATOR

Placebo Group

Intervention Type: DIETARY_SUPPLEMENT

Participants in this arm will take 2 spoons (15g) twice per day for 12 weeks

Interventions

All-plant Protein Booster Product Group

Participants in this arm will take 2 spoons (15g) twice per day for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo Group

Participants in this arm will take 2 spoons (15g) twice per day for 12 weeks

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Be age 50 to 70 years, female and male
• Participants will be required to have mild to moderately OA & SA evaluated by Kellgren-Lawrence I-II and SARC-Cal, respectively
• Participants need to be competent i.e., able to understand what is to take place and able to provide a free decision on agreeing to the activity/taking part on the study on this
• Participants must be able to read and understand study instructions and any other relevant study documents
• Willing to following the lifestyle restrictions as detailed in the Information Sheet for study
• Will to give written informed consent

Exclusion Criteria

• Have a fever currently, or for 24 hours before enrollment
• Currently participating in another clinical study
• Have taken other protein powder products and dietary supplements or medicines containing peptides or hyaluronic acid within the past 6 months (subject to product instructions)
• Individuals receiving medical treatment that, in the opinion of the Principal Investigator or Study Physician, may interfere with test results
• The participant is an employee of Amway or SPRIM Medical
• Subject who is in the treatment of gastrointestinal diseases
• Subject with abnormal liver function tests (alanine aminotransferase and aspartate aminotransferase), kidney function tests (blood urea nitrogen and creatinine), blood routine, urine routine, fecal occult blood test, or electrocardiogram.
• Subjects have any of the following medical history or have been clinically examined to have the following diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amway (China) R&D Center

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhenzhong Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Jinhua Wenrong Hospital

Locations

Jinhua Wenrong Hospital

Jinhua, Zhejiang, China

Countries

China

Other Identifiers

IS20220021RD

Identifier Type: -

Identifier Source: org_study_id