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Exploratory research for the autophagy-related efficacy of urolithin in healthy Japanese women

Exploratory research for the autophagy-related efficacy of urolithin in healthy Japanese women: a randomized, dose-controlled, open-label, parallel-group comparison study - Exploratory research for the autophagy-related efficacy of urolithin in healthy Japanese women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048437
Enrollment
56
Registered
2022-07-22
Start date
2022-07-25
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: Capsule containing urolithin Administration: Take one capsule with water (10 mg of urolithin per day) *If you forget to take the test food, take it as soon as you re

Sponsors

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

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Women 3. Adults 4. Healthy subjects

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, hypotension, 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 use herb or supplements with antihypertensive effects, or use antihypertensive drugs such as angiotensin-converting enzyme inhibitor 7. Subjects who use anticoagulant agent 8. Subjects who are allergic to medicines and/or the test food related products 9. Subjects who are pregnant, lactation, or planning to become pregnant during this trial 10. Subjects who suffer from COVID-19 11. 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 12. Subjects who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

MeasureTime frame
Skin evaluation {gloss value, diffuse scattering correction, viscoelasticity, melanin, erythema, intensity, skin thickness, low echogenic band (LEB)}, wrinkle grade, savin scale, hair analysis (mean hair length, the percentage of anagen hairs, the percentage of telogen hairs, the density of vellus hair, the density of terminal hair, the ratio of vellus hair, the ratio of terminal hair), the age of skin, and skin health level at 12 weeks after consumption (12w)

Secondary

MeasureTime frame
Body mass index, body fat percentage, lean body mass, muscle mass {right arm, left arm, right leg, left leg, and trunk (torso)}, fat mass {right arm, left arm, right leg, left leg, and trunk (torso)}, waist circumference, urolithin in the urine, and each item of an original questionnaire 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