Verification Study of the Effects of Consumption of the Test Food on the Musculoskeletal System (NCT07729657) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Verification Study of the Effects of Consumption of the Test Food on the Musculoskeletal System
Japan80 participantsStarted 2026-07-30
Plain-language summary
The goal of this clinical trial is to test the effects of the test products on the locomotor system in healthy Japanese adults with low muscle mass and knee joint discomfort. The main question it aims to answer is:
• Does the daily consumption of the test product improve subjective knee symptoms, quality of life (QOL), and physical function?
Participants will be asked to:
* Take 3 capsules of the test product daily for 12 weeks.
* Complete questionnaires regarding subjective knee symptoms and QOL.
* Undergo bilateral X-ray imaging.
* Undergo assessment of lower limb extension strength.
* Perform the stand-up test to evaluate lower limb muscle endurance.
* Perform the 10-meter walk test to evaluate walking ability.
* Undergo anthropometric and physical measurements. Researchers will compare Test Product 1, Test Product 2, and Test Product 3, against a placebo group to see if consumption of the study products improves knee symptoms, QOL, and physical function.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Japanese
. Men or women
. Adults
. Healthy individuals
. Individuals whose body mass index is ≥18.5 and \<30 kg/m2
. Individuals who have low whole-body muscle mass
. Individuals with KL grades of 0 or I on radiographic examination
. Individuals with high knee pain intensity using the JKOM, as measured by VAS
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Knee pain intensity evaluated by Visual Analogue Scale (VAS)
. Individuals receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction
. Individuals with an implanted pacemaker or implantable cardioverter-defibrillator
. Individuals undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
. Individuals consuming Foods for Specified Health Uses (FOSHU) or FFC
. Individuals taking or using medications (including herbal medicines) or supplements
. Individuals who are allergic to medications or foods related to the test product
. Individuals engaging at least 60 minutes per week in physical activity that induces heavy breathing and sweating
. Individuals engaging in strength training (including bodyweight exercises such as push-ups), running, walking, cycling, or swimming at least twice a week