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

NCT06499012 | Completed

• 1 other identifier: IS20220021RD
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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

Keywords

Amway Nutrilite; All-plant Protein Booster; SPPB; WOMAC; WHOQOL BREF; SF-36; CFQ 11; SFQ

Outcome Measures

Primary Outcomes (2)

• Change of SPPB Score from baseline

  The SPPB (Short Physical Performance Battery) test is a group of measures that combines the results of the gait speed, chair stand and balance tests (Guralnik et al., 2000). lt has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance).

  baseline day 0, week 12

• Change of WOMAC 3.1 index from baseline

  The WOMAC (Western Ontario and McMaster Universities Arthritis) Index was created to assess pain, stiffness, and physical function in patients with hip and / or knee osteoarthritis (OA). The WOMAC 3.1 consists of 24 items divided into 3 subscales. The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A total WOMAC score is created by summing the items for all three subscales. (0-96), higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  baseline day 0, week 12

Secondary Outcomes (6)

• Change of bone density measured by DXA Bone Densitometer from baseline

  baseline day 0, week 12

• Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline

  baseline day 0, week 12

• Improvement of Quality of Life by WHOQOL BREF

  baseline day 0, week 12

• Improvement of Quality of Life by SF-36

  baseline day 0, week 12

• Improvement of Quality of Life by Chalder Fatigue Scale (CFQ 11)

  baseline day 0, week 12

Study Arms (2)

All-plant Protein Booster Product Group

ACTIVE COMPARATOR

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)

Dietary Supplement: All-plant Protein Booster Product Group

Placebo Group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo Group

Interventions

All-plant Protein Booster Product Group DIETARY_SUPPLEMENT

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

All-plant Protein Booster Product Group

Placebo Group DIETARY_SUPPLEMENT

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

Placebo Group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amway (China) R&D Center: lead

Study Sites (1)

Jinhua Wenrong Hospital

Jinhua, Zhejiang, China

Location

MeSH Terms

Conditions

Osteoarthritis; Sarcopenia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Zhenzhong Lu, MD

  Jinhua Wenrong Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 12, 2024
• Study Start: July 8, 2025
• Primary Completion: October 2, 2025
• Study Completion: October 2, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)