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Safety evaluation of an excessive consumption of test food

Safety evaluation of an excessive consumption of test food - Safety evaluation of an excessive consumption of test food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056276
Enrollment
60
Registered
2024-11-27
Start date
2024-12-24
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 Adults

Interventions

Ingestion of Test food A containing 5 folds dose of recommended daily intake of the functional substance, for 4 weeks. Ingestion of Test food B containing 5 folds dose of recommended daily intake of t

Sponsors

Meiji Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Males and females from 50 to under 75 years of age. 2. Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects who have a history or current illness of serious diseases such as brain disease, malignant tumor, immune disease, kidney disease, liver disorder, cardiovascular disorder, respiratory disorder, endocrine disorder, or other metabolic disorders. 2. Subjects who have a history of drug dependence or alcohol dependence or have a current medical history. 3. Subjects who have a history of gastrointestinal disease or gastrointestinal surgery that affects digestion and absorption. (excluding appendicitis) 4. Subjects who have been diagnosed with dementia by a doctor. 5. Subjects who are judged to be inappropriate as research subjects according to blood tests in screening tests. 6. Subjects who has food allergy. 7. Subjects who cannot consume cheese every day. 8. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. 9. Subjects who has participated in blood collection or donation of more than 200 mL within 1 month or more than 400 mL within 3 months prior to the date of obtaining consent. 10. Subjects who have a habit of consuming Camembert cheese (2 pieces a day, 5 days a week or more). 11. Subjects who consistently drink more than the recommended amount of alcohol (average net alcohol intake of over 40 g/day, 4 days a week or more). 12. Subjects who have irregular lifestyles due to night shifts or shift work. 13. Subjects with extremely irregular lifestyle habits in terms of eating and sleeping. 14. Subjects who cannot receive refrigerated deliveries. 15. Subjects who are participating in other clinical studies that require taking foods, pharmaceuticals, or using cosmetics now, or are willing to participate within 3 months prior to the date of obtaining consent. 16. Subjects who are judged unsuitable for the study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Number of adverse events, number of cases, and frequency of adverse events related to the intake of the study foods, medical interview, weight/body mass index, blood pressure/pulsation, hematologic test, blood biochemistry test, urine analysis and Pittsburgh Sleep Quality Index

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

yoshikawa@kso.co.jp03-3452-7733

Outcome results

None listed

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