Osteoarthritis, Sarcopenia
Conditions
Keywords
Amway Nutrilite, All-plant Protein Booster, SPPB, WOMAC, WHOQOL BREF, SF-36, CFQ 11, SFQ
Brief 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. 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
Interventions
DIETARY_SUPPLEMENTAll-plant Protein Booster Product Group
Participants in this arm will take 2 spoons (15g) twice per day for 12 weeks
DIETARY_SUPPLEMENTPlacebo Group
Participants in this arm will take 2 spoons (15g) twice per day for 12 weeks
Sponsors
Amway (China) R&D Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of SPPB Score from baseline | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Quality of Life by WHOQOL BREF | baseline day 0, week 12 | WHOQOL-BREF is a generic health related QoL measure consisting of 26 items divided into 6 sub-scales. |
| Improvement of Quality of Life by SF-36 | 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. |
| Change of bone density measured by DXA Bone Densitometer from baseline | baseline day 0, week 12 | Change of bone density measured by DXA Bone Densitometer from baseline to week 12 |
| Change of SFQ from baseline | baseline day 0, week 12 | The change of frequency of sports activity by SFQ (Sports Frequency Questionnaire) from baseline to week 12 |
| Improvement of Quality of Life by Chalder Fatigue Scale (CFQ 11) | 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. |
| Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline | baseline day 0, week 12 | Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline to week 12 |
Countries
China
Outcome results
None listed