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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Placebo Group | Placebo Comparator | Containing ingredients: Aloe Vera powder, Sweetener (Maltitol) Anti-caking (Silicon Dioxide) Thickener (guar gum, arabic gum) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| All-plant Protein Booster Product Group | Dietary Supplement | Participants in this arm will take 2 spoons (15g) twice per day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline day 0, week 12 |
| Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhenzhong Lu, MD | Jinhua Wenrong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinhua Wenrong Hospital | Jinhua | Zhejiang | China |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Placebo Group | Dietary Supplement | Participants in this arm will take 2 spoons (15g) twice per day for 12 weeks |
|
Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline to week 12 |
| 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. | 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. | 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. | 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 | baseline day 0, week 12 |
| D009133 |
| Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |