An exploratory study on the effects of continuous intake of a test food on muscle strength, muscle mass, and walking ability in middle-aged and older adults. -Randomized, placebo-controlled, double-blind, parallel group study-

An exploratory study on the effects of continuous intake of a test food on muscle strength, muscle mass, and walking ability in middle-aged and older adults. -Randomized, placebo-controlled, double-blind, parallel group study- - An exploratory study on the effects of continuous intake of a test food on muscle strength, muscle mass, and walking ability in middle-aged and older adults.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000058369

Enrollment

Registered

2025-07-04

Start date

2025-08-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intake of active food for 12 weeks Intake of placebo food for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Males and females aged of 50-69 years 2)Participants who are judged by the investigator or sub-investigator not to have difficulty exercising 3)Participants who can visit on schedule days 4)Participants who recognize the object and contents of the study and submit the written informed consent

Exclusion criteria

Exclusion criteria: 1)Participants with a history of serious cardiac disease (e.g. heart failure, myocardial infarction, myocarditis) 2)Participants with a history or current history of serious disease (liver, kidney, cardiovascular, gastrointestinal, pulmonary, hematologic, metabolic) 3)Participants who have experienced syncope or transient visual loss 4)Participants with musculoskeletal disorders (except for those who are deemed eligible to participate by the study investigator) 5)Participants taking medications that affect heart rate 6)Participants who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study and who have difficulty with daily living or exercise 7)Individuals who regularly consume, or plan to consume during the study, health foods or supplements that may affect the study 8)Heavy drinker (over 40g alcohol/day) 9)Smokers (over 21 smoking/day) 10)Participants who regularly engage in strenuous physical activity 11)Participants who have allergy related to the test foods 12)Participants who are already participating in other clinical trials, those who plan to participate during this study period, and those within one month after the completion of the trial in which they participated 13)Participants who are ineligible due to physician's judgment

Design outcomes

Primary

Measure	Time frame
Motor function tests	—

Secondary

Measure	Time frame
Physical examination, QOL Questionnaire	—

Countries

Japan

Contacts

Public ContactToyotada Ashino

Trans Genic Inc. Clinical Research Department

toyotada.ashino@transgenic.co.jp0123-34-0412

Outcome results