To Investigate Effects of Amway Bundle Combination of Products on Osteoarthritis & Sarcopenia
NCT ID: NCT05872360
Last Updated: 2024-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2023-05-27
2024-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Bundle Group 1 with Nutrilite Lifestyle
Amway 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
Bundle Group 1 with Nutrilite Lifestyle
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 Lifestyle
Amway 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)
Bundle Group 2 without Nutrilite Lifestyle
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 1
Placebo for all-plant protein booster: 450g/bottle, containing the following ingredients: Maltodextrin
Control Group 1
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 Lifestyle
Placebo for all-plant protein booster: 450g/bottle, containing the following ingredients: Maltodextrin
Nutrition Guideline: Nutrilite Lifestyle
Control Group 2 with Nutrilite Lifestyle
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.
Interventions
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Bundle Group 1 with Nutrilite Lifestyle
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 Lifestyle
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 1
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 Lifestyle
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
50 Years
70 Years
ALL
Yes
Sponsors
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Amway (China) R&D Center
INDUSTRY
Responsible Party
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Principal Investigators
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Charlie Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
SPRIM Medical
Locations
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Raison Healthcare Lab
Shanghai, Shanghai Municipality, China
Raison Healthcare R&D Center
Shanghai, Shanghai Municipality, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Wakabayashi H, Sakuma K. Comprehensive approach to sarcopenia treatment. Curr Clin Pharmacol. 2014 May;9(2):171-80. doi: 10.2174/1574884708666131111192845.
Other Identifiers
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22-SM-09-AY-001
Identifier Type: -
Identifier Source: org_study_id
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