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Examination of changes in blood hormone levels due to intake of test food

Examination of changes in blood hormone levels due to intake of test food -Single-arm open study- - Examination of changes in blood hormone levels due to intake of test food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049793
Enrollment
50
Registered
2022-12-16
Start date
2022-12-20
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 individuals

Interventions

Ingestion of test food for 90 days

Sponsors

ROHTO Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1) Healthy female subjects aged between 25and 42 years at the time of informed consent (2) Subjects with a stable menstrual cycle (3) Subjects whose blood AMH is 0.5 ng/mL or more and less than 3.0 ng/mL (4) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.

Exclusion criteria

Exclusion criteria: (1) Subjects with heart, liver, or kidney disease (including complications of other diseases) (2) Subjects with a history of cardiovascular disease (3) Subjects with diabetes (4) Subjects who suffer from diseases that may affect the results of the study, or who are undergoing treatment (5) Subjects with food and drug allergies (6) Subjects with symptoms of anemia that interfere with daily life (7) Female subjects who wish to become pregnant, who are pregnant (including those who may be pregnant), or who are breastfeeding while participating in this study (8) Subjects using female sex hormones, pyrroloquinoline quinone, coenzyme Q10 (9) Subjects who participate in strenuous sports and who are on a diet (10) Subjects with extremely irregular eating habits (11) Subjects who consume more than 60 g of pure alcohol per day (12) Subjects with a smoking habit (13) Subjects with a BMI of 30 or higher (14) Subjects participating in or planning to participate in other clinical trials at the start of this study (15) Subjects who are otherwise judged by the principal investigator or subinvestigator to be unsuitable for the study

Design outcomes

Primary

MeasureTime frame
blood hormone levels

Secondary

MeasureTime frame
sex hormones oxidation marker MDQ

Countries

Japan

Contacts

Public ContactMakoto Terashima

Oneness Support Co., Ltd. Clinical Trial Division

mterashima@oneness-sup.co.jp06-4801-8917

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 12, 2026