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A verification study of the prevention of frailty

A verification study of the prevention of frailty: a randomized, placebo-controlled, double-blind, parallel-group comparison study - A verification study of the prevention of frailty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049004
Enrollment
60
Registered
2022-09-22
Start date
2022-09-22
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 Take test food with water or hot water. *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to th

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 60 or more 4. Healthy subjects 5. Subjects whose scoring of Mini Mental State Examination (MMSE) is 24 or more 6. Subjects whose gait speed is relatively low

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" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who consciously take dietary fiber and oligosaccharides 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who have an exercise habit of two times or more per week and 30 minutes or more each time, and been doing it for one year or more 9. Subjects who suffer from COVID-19 10. 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 11. Subjects who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

MeasureTime frame
Physical characteristic check up Cognitive function tests QoL questionnaire Blood markers test

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