Verification Study of the Effects of Consumption of the Test Food on the Musculoskeletal System | NCT07729657

NCT07729657

Overview

NCT ID: NCT07729657
Lead Sponsor: Bloomage Biotechnology Corp., Ltd.INDUSTRY
Official Title: Verification Study of the Effects of Consumption of the Test Food on the Musculoskeletal System: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Jul 30, 2026Estimated
Primary Completion Date: Dec 14, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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:

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

Individuals who are pregnant, lactating, or planning to become pregnant during the study period

Individuals usually taking FOSHU or FFC, e.g., NAG, proteoglycan from salmon nasal cartilage (SNC), undenatured type II collagen from SNC, glucosamine hydrochloride, curcumin, elastin peptide from skipjack, or collagen peptide

Individuals engaging in intense knee joint-loading exercise (e.g., ball sports, such as soccer, baseball, and basketball, jogging, running, skiing, or snowboarding)

Individuals who use a cane or joint support, or may use them during this study

Individuals deemed unsuitable to participate in this study by the principal investigator

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 80Estimated
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Contacts and Locations

Central Contacts: Naoko SuzukiContact
group_gakujutsu@orthomedico.jp+81-3-3818-0610

Similar Studies

Participant Group/Arms

NAG + HA + PQQ groupActive Comparator

Participants in this arm will consume the active study product containing N-acetylglucosamine (NAG), hyaluronic acid (HA), and pyrroloquinoline quinone (PQQ).

Dietary Supplement: Food containing NAG, HA, and PQQ

NAG + HA groupActive Comparator

Participants in this arm will consume the active study product containing NAG and HA.

Dietary Supplement: Food containing NAG and HA

NAG groupActive Comparator

Participants in this arm will consume the active study product containing NAG.

Dietary Supplement: Food containing NAG

Placebo groupPlacebo Comparator

Participants in this arm will consume a placebo product visually and organoleptically identical to the active products but without the active ingredients.

Dietary Supplement: Placebo