Clinical trial NCT06499012: The Efficacy of Nutrilite All-plant Protein Booster to Improve Sarcopenia and Osteoarthritis in Middle-aged and Elderly People
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Sarcopenia
Keywords: Amway Nutrilite
All-plant Protein Booster
SPPB
WOMAC
WHOQOL BREF
SF-36
CFQ 11
SFQ
Lead sponsor: Amway (China) R&D Center
Sponsor class: INDUSTRY
First posted: 2024-07-12
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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-III 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

Primary outcomes:
measure: Change of SPPB Score from baseline
timeFrame: baseline day 0, week 12
measure: Change of WOMAC 3.1 index from baseline
timeFrame: baseline day 0, week 12
Secondary outcomes:
measure: Change of bone density measured by DXA Bone Densitometer from baseline
timeFrame: baseline day 0, week 12
measure: Improvement of Fat and Muscle Portions measured by Inbody S10 from baseline
timeFrame: baseline day 0, week 12
measure: Improvement of Quality of Life by WHOQOL BREF
timeFrame: baseline day 0, week 12
measure: Improvement of Quality of Life by SF-36
timeFrame: baseline day 0, week 12
measure: Improvement of Quality of Life by Chalder Fatigue Scale (CFQ 11)
timeFrame: baseline day 0, week 12
measure: Change of SFQ from baseline
timeFrame: baseline day 0, week 12
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Jinhua Wenrong Hospital
state: Zhejiang
Study officials:
affiliation: Jinhua Wenrong Hospital
name: Zhenzhong Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: