Skip to content

Effects of consumption of the test food on walking function and body composition in healthy subjects aged 40 or more

Effects of consumption of the test food on walking function and body composition in healthy subjects aged 40 or more: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on walking function and body composition in healthy subjects aged 40 or more

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052467
Enrollment
52
Registered
2023-10-11
Start date
2023-10-11
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

Healthy Japanese subjects

Interventions

Duration: 12 weeks Test food: Lipid compounds Administration: Take one capsule (200 mg) per day. *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 40 or more 4. Healthy subjects 5. The average number of daily steps is 8000 or more per day in the last one week including the time of the agreement to participate in this trial or the average number of daily steps is 5000 or less per day in the last one week including the time of the agreement to participate in this trial 6. The bottom 52 subjects with low muscle mass among those who meet inclusion criteria No.1~5 without meeting any of exclusion criteria

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" 5. Subjects who are taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

MeasureTime frame
1. The walking speed at 12 weeks after consumption (12w) 2. The muscle mass at 12w

Secondary

MeasureTime frame
1. Walking time, number of steps, stride length, walking rate (the number of steps per time), grip strength, body weight, body mass index, body fat percentage, fat mass, lean body mass, and body water at 12w

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026