OsteoarthritisNCT06499012
The Efficacy of Nutrilite All-plant Protein Booster to Improve Sarcopenia and Osteoarthritis in Middle-aged and Elderly People
A study testing All-plant Protein Booster Product Group in people with Osteoarthritis and Sarcopenia, run by Amway (China) R&D Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Sarcopenia
- What is being tested?
- All-plant Protein Booster Product Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2025to 2 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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?
Read more
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
- Being tested
- All-plant Protein Booster Product Group, Placebo Group
- Keywords
- Amway Nutrilite, All-plant Protein Booster, SPPB, WOMAC, WHOQOL BREF, SF-36, CFQ 11, SFQ
- Medical subject headings
- Osteoarthritis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All-plant Protein Booster Product GroupDietary supplement
Participants in this arm will take 2 spoons (15g) twice per day for 12 weeks
Placebo GroupDietary supplement
Participants in this arm will take 2 spoons (15g) twice per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Dietary Supplement: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: baseline day 0, week 12
Secondary outcomes (6)
Change of bone density measured by DXA Bone Densitometer from baseline
Change of bone density measured by DXA Bone Densitometer from baseline to week 12
Measured: baseline day 0, week 12
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 week 12
Measured: baseline day 0, week 12
Improvement of Quality of Life by WHOQOL BREF
WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales.
Measured: baseline day 0, week 12
Improvement of Quality of Life by SF-36
The 36-Item Short Form Survey (SF-36) is an outcome measure instrument that comprises 36 questions that cover eight domains of health.
Measured: baseline day 0, week 12
Improvement of Quality of Life by Chalder Fatigue Scale (CFQ 11)
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.
Measured: baseline day 0, week 12
Change of SFQ from baseline
The change of frequency of sports activity by SFQ (Sports Frequency Questionnaire) from baseline to week 12
Measured: baseline day 0, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start8 Jul 2025
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amway (China) R&D Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhenzhong Lu, MD, Principal investigator, Jinhua Wenrong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499012
- Sponsor's protocol ID
- IS20220021RD
- Status last verified
- Nov 2025
- First submitted
- 6 Jul 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06499012
- Acronym / sponsor ID
- IS20220021RD
- Conditions
- Osteoarthritis, Sarcopenia
- Keywords
- Amway Nutrilite, All-plant Protein Booster, SPPB, WOMAC, WHOQOL BREF, SF-36, CFQ 11, SFQ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Amway (China) R&D CenterIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All-plant Protein Booster Product Group | Active comparator | Dietary Supplement: All-plant Protein Booster Product GroupContaining 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) |
| Placebo Group | Placebo comparator | Dietary Supplement: Placebo GroupContaining ingredients: Aloe Vera powder, Sweetener (Maltitol) Anti-caking (Silicon Dioxide) Thickener (guar gum, arabic gum) |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All-plant Protein Booster Product GroupParticipants in this arm will take 2 spoons (15g) twice per day for 12 weeks | Dietary supplement | All-plant Protein Booster Product Group |
| Placebo GroupParticipants in this arm will take 2 spoons (15g) twice per day for 12 weeks | Dietary supplement | Placebo Group |
Primary outcome
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).
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.
6 secondary outcomes
Change of bone density measured by DXA Bone Densitometer from baseline
Time frame: baseline day 0, week 12
Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline
Time frame: baseline day 0, week 12
Improvement of Quality of Life by WHOQOL BREF
Time frame: baseline day 0, week 12
Improvement of Quality of Life by SF-36
Time frame: baseline day 0, week 12
Improvement of Quality of Life by Chalder Fatigue Scale (CFQ 11)
Time frame: baseline day 0, week 12
Change of SFQ from baseline
Time frame: baseline day 0, week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenzhong Lu, MD principal investigator
Jinhua Wenrong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All-plant Protein Booster Product Group in people with Osteoarthritis and Sarcopenia, run by Amway (China) R&D Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of SPPB Score from baseline (time frame: baseline day 0, week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.