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Completed

NCT Number: NCT06499012

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

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

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Key information

Conditions

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

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinhua Wenrong Hospital

Jinhua, Zhejiang, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

All-plant Protein Booster Product Group

Dietary Supplement

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

Placebo Group

Dietary Supplement

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

Primary outcomes

  1. Change of SPPB Score from baseline

    Time frame: baseline day 0, week 12

    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).

  2. Change of WOMAC 3.1 index from baseline

    Time frame: baseline day 0, week 12

    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.

Secondary outcomes

  1. Change of bone density measured by DXA Bone Densitometer from baseline

    Time frame: baseline day 0, week 12

    Change of bone density measured by DXA Bone Densitometer from baseline to week 12

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

    Time frame: baseline day 0, week 12

    Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline to week 12

  3. Improvement of Quality of Life by WHOQOL BREF

    Time frame: baseline day 0, week 12

    WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales.

  4. Improvement of Quality of Life by SF-36

    Time frame: baseline day 0, week 12

    The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that comprises 36 questions that cover eight domains of health.

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

    Time frame: baseline day 0, week 12

    Change of Chalder Fatigue Scale (CFQ 11), with range from 0 to 11 (the bigger the score, the more fatigue a person feels), from baseline to week 12. The Chalder fatigue scale (CFQ 11) is a questionnaire created by the research team of Trudie Chalder at King's College London to measure the severity of tiredness in fatiguing illnesses.

  6. Change of SFQ from baseline

    Time frame: baseline day 0, week 12

    The change of frequency of sports activity by SFQ (Sports Frequency Questionnaire) from baseline to week 12

Sponsors and collaborators

Lead sponsor

Amway (China) R&D Center

Industry

Registry information

Official study title

A Randomized, Double-blind Clinical Study of the Efficacy of Nutrilite All-plant Protein Booster to Improve Sarcopenia and Osteoarthritis in Middle-aged and Elderly People

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2024
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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