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Safety-confirmation of excessive ingestion of test food

Safety-confirmation of excessive ingestion of test food - Safety-confirmation of excessive ingestion of test food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047547
Enrollment
15
Registered
2023-04-27
Start date
2022-04-27
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 the test food (5 packages/day) to the subjects for 4 weeks.

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy subjects ranging in age from 20 to 64, at the moment of giving informed consent to take part in this research. (2) Subjects who can give informed consent to participate in this research after being provided with an explanation of our experimental protocol detail.

Exclusion criteria

Exclusion criteria: (1) Subjects who take steadily in the health-specific/functional/supplementary/health foods, and will have any difficulty in giving up taking them after the consent. (2) Subjects who have taken some kind of medicine, and have any difficulty in refraining from taking them during this research. (3) Subjects with excessive alcohol intake. (4) Subjects with current and/or previous medical history of serious diseases in heart, liver, kidney and/or digestive organs. (5) Pregnant, possibly pregnant women during this research, or lactating ones. (6) Subjects with drug and/or food allergy. (7) Subjects who are now under other clinical researches with some kind of medicine/food, or participated in those within four weeks before this research, or planning to join those after the consent. (8) Subjects who donated over 200 mL of their blood and/or blood components within a month to this research. (9) Males who donated their whole blood (400 mL) within the last three months to this research. (10) Females who donated their whole blood (400 mL) within the last four months to this research. (11) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this research. (12) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this research. (13) Others who have been determined as ineligible for participation in this research, according to the principal/sub investigator's opinions.

Design outcomes

Primary

MeasureTime frame
Incidence of some kind of adverse event and/or side effect. Changes in clinical examination values.

Countries

Japan

Contacts

Public ContactMasanori Numa

CPCC Company Limited Clinical Planning Department

cpcc-contact@cpcc.co.jp03-6225-9001

Outcome results

None listed

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