The Efficacy of Nutrilite All-plant Protein Booster to Improve Sarcopenia and Osteoarthritis in Middle-aged and Elderly People

Amway

Status

Not yet enrolling

Conditions

Osteoarthritis

Sarcopenia

Treatments

Dietary Supplement: All-plant Protein Booster Product Group

Dietary Supplement: Placebo Group

Study type

Interventional

Funder types

Industry

Identifiers

NCT06499012

IS20220021RD

Details and patient eligibility

About

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

Enrollment

160 estimated patients

Sex

All

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

160 participants in 2 patient groups, including a placebo group

All-plant Protein Booster Product Group

Active Comparator group

Description:

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)

Treatment:

Dietary Supplement: All-plant Protein Booster Product Group

Placebo Group

Placebo Comparator group

Description:

Containing ingredients: Aloe Vera powder, Sweetener (Maltitol) Anti-caking (Silicon Dioxide) Thickener (guar gum, arabic gum)

Treatment:

Dietary Supplement: Placebo Group