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OsteoarthritisNCT05872360

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

A study testing Bundle Group 1 with Nutrilite Lifestyle and Bundle Group 2 without Nutrilite Lifestyle in people with Osteoarthritis and Sarcopenia, run by Amway (China) R&D Center at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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?
Bundle Group 1 with Nutrilite Lifestyle and Bundle Group 2 without Nutrilite Lifestyle
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
2 sitesChina
Study dates
27 May 2023to 28 Feb 2024
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

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Raison Healthcare Lab

    Shanghai, Shanghai Municipality

  • Raison Healthcare R&D Center

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Randomized, Double-blind Controlled Trial to Investigate Effects of Amway Bundle Combination of Products on Osteoarthritis & Sarcopenia

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.

Being tested
Bundle Group 1 with Nutrilite Lifestyle, Bundle Group 2 without Nutrilite Lifestyle, Control Group 1, Control Group 2 with Nutrilite Lifestyle
Keywords
Amway, Nutrilite Lifestyle, EMS (Electric Muscle Stimulation)
Medical subject headings
Osteoarthritis, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bundle Group 1 with Nutrilite LifestyleDietary supplement

    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.

  • Bundle Group 2 without Nutrilite LifestyleDietary supplement

    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.

  • Control Group 1Dietary supplement

    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.

  • Control Group 2 with Nutrilite LifestyleDietary supplement

    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.

Study groups in NCT05872360
Study groupRoleWhat they receive
Bundle Group 1 with Nutrilite LifestyleActive comparatorAmway 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
Receives: Dietary Supplement: Bundle Group 1 with Nutrilite Lifestyle
Bundle Group 2 without Nutrilite LifestyleActive comparatorAmway 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)
Receives: Dietary Supplement: Bundle Group 2 without Nutrilite Lifestyle
Control Group 1Placebo comparatorPlacebo for all-plant protein booster: 450g/bottle, containing the following ingredients: Maltodextrin
Receives: Dietary Supplement: Control Group 1
Control Group 2 with Nutrilite LifestylePlacebo comparatorPlacebo for all-plant protein booster: 450g/bottle, containing the following ingredients: Maltodextrin Nutrition Guideline: Nutrilite Lifestyle
Receives: Dietary Supplement: Control Group 2 with Nutrilite Lifestyle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline day 0, day 180

Secondary outcomes (6)

  1. Change of WOMAC Questionnaire Scores from baseline

    Change of WOMAC Questionnaire Scores from baseline to day 90 and day 180

    Measured: baseline day 0, day 90, day 180

  2. 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

    Measured: baseline day 0, day 90, day 180

  3. 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

    Measured: baseline day 0, day 90, day 180

  4. 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

    Measured: baseline day 0, day 90, day 180

  5. 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

    Measured: baseline day 0, day 90, day 180

  6. 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

    Measured: baseline day 0, day 90, day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2023
  2. Study start27 May 2023
  3. Primary completion28 Feb 2024
  4. Study completion28 Feb 2024

Resources

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
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05872360
Sponsor's protocol ID
22-SM-09-AY-001
Status last verified
Apr 2024
First submitted
14 May 2023
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Basat S, Sivritepe R, Ortaboz D, Sevim E, Atay S, Baygul A. The Relationship Between Osteoarthritis and Sarcopenia in Geriatric Diabetic Patients. Sisli Etfal Hastan Tip Bul. 2021 Dec 29;55(4):516-523. doi: 10.14744/SEMB.2021.42890. eCollection 2021.

    PubMed 35317381

  • Zhong J, Xie W, Wang X, Dong X, Mo Y, Liu D, Yao X, Liu B, Deng W, Su Y, Li Y, Wang X. The Prevalence of Sarcopenia among Hunan Province Community-Dwelling Adults Aged 60 Years and Older and Its Relationship with Lifestyle: Diagnostic Criteria from the Asian Working Group for Sarcopenia 2019 Update. Medicina (Kaunas). 2022 Oct 30;58(11):1562. doi: 10.3390/medicina58111562.

    PubMed 36363519

  • Pickering ME, Chapurlat R. Where Two Common Conditions of Aging Meet: Osteoarthritis and Sarcopenia. Calcif Tissue Int. 2020 Sep;107(3):203-211. doi: 10.1007/s00223-020-00703-5. Epub 2020 May 18.

    PubMed 32424600

  • De Ceuninck F, Fradin A, Pastoureau P. Bearing arms against osteoarthritis and sarcopenia: when cartilage and skeletal muscle find common interest in talking together. Drug Discov Today. 2014 Mar;19(3):305-11. doi: 10.1016/j.drudis.2013.08.004. Epub 2013 Aug 20.

    PubMed 23973339

  • Matada MS, Holi MS, Raman R, Jayaramu Suvarna ST. Visualization of Cartilage from Knee Joint Magnetic Resonance Images and Quantitative Assessment to Study the Effect of Age, Gender and Body Mass Index (BMI) in Progressive Osteoarthritis (OA). Curr Med Imaging Rev. 2019;15(6):565-572. doi: 10.2174/1573405614666181018123251.

    PubMed 32008564

  • Smith D, Knapp PK, Wright DC, Hollick DR. Dual Energy X-Ray Absorptiometry (DXA) Extended Femur Scans to Support Opportunistic Screening for Incomplete Atypical Femoral Fractures: A Short Term in-vivo Precision Study. J Clin Densitom. 2023 Apr-Jun;26(2):101352. doi: 10.1016/j.jocd.2022.12.005. Epub 2022 Dec 8.

    PubMed 36740545

  • Lee SY, Choo PL, Pang BWJ, Lau LK, Jabbar KA, Seah WT, Chen KK, Ng TP, Wee SL. SPPB reference values and performance in assessing sarcopenia in community-dwelling Singaporeans - Yishun study. BMC Geriatr. 2021 Mar 30;21(1):213. doi: 10.1186/s12877-021-02147-4.

    PubMed 33781211

  • Marcos-Pardo PJ, Gonzalez-Galvez N, Carbonell-Baeza A, Jimenez-Pavon D, Vaquero-Cristobal R. GDLAM and SPPB batteries for screening sarcopenia in community-dwelling Spanish older adults: Healthy-age network study. Exp Gerontol. 2023 Feb;172:112044. doi: 10.1016/j.exger.2022.112044. Epub 2022 Dec 9.

    PubMed 36509296

  • Petrella RJ, DiSilvestro MD, Hildebrand C. Effects of hyaluronate sodium on pain and physical functioning in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled clinical trial. Arch Intern Med. 2002 Feb 11;162(3):292-8. doi: 10.1001/archinte.162.3.292.

    PubMed 11822921

  • Doshi R, Ostrovsky D. Glucosamine may be Effective in Treating Pain due to Knee Osteoarthritis. Explore (NY). 2019 Jul-Aug;15(4):317-319. doi: 10.1016/j.explore.2019.04.007. Epub 2019 May 4. No abstract available.

    PubMed 31229448

  • Train A, Moe S, Allan GM. Are glucosamine and chondroitin natural remedies for osteoarthritis? Can Fam Physician. 2021 Feb;67(2):111. doi: 10.46747/cfp.6702111. No abstract available.

    PubMed 33608362

  • Angelides S, Manolios N. Correspondence on 'Glucosamine and O-GlcNAcylation: a novel immunometabolic therapeutic target for OA and chronic, low-grade systemic inflammation?'. Ann Rheum Dis. 2023 Mar;82(3):e57. doi: 10.1136/annrheumdis-2020-219694. Epub 2021 Jan 27. No abstract available.

    PubMed 33504484

  • Welch C, Majid Z, Greig C, Gladman J, Masud T, Jackson T. Interventions to ameliorate reductions in muscle quantity and function in hospitalised older adults: a systematic review towards acute sarcopenia treatment. Age Ageing. 2021 Feb 26;50(2):394-404. doi: 10.1093/ageing/afaa209.

    PubMed 33098419

  • Wakabayashi H, Sakuma K. Comprehensive approach to sarcopenia treatment. Curr Clin Pharmacol. 2014 May;9(2):171-80. doi: 10.2174/1574884708666131111192845.

    PubMed 24219006

Questions about this trial

What is this clinical trial studying?

A study testing Bundle Group 1 with Nutrilite Lifestyle and Bundle Group 2 without Nutrilite Lifestyle in people with Osteoarthritis and Sarcopenia, run by Amway (China) R&D Center at 2 sites 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 5 inclusion and 10 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 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Short Physical Performance Battery (SPPB) score from baseline (time frame: baseline day 0, day 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05872360, which also lists 14 linked publications.

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 9 Apr 2024.

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