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Safety Evaluation for Long-term Intake of a Test Food

Safety Evaluation for Long-term Intake of a Test Food - Safety Evaluation for Long-term Intake of a Test Food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000039098
Enrollment
20
Registered
2020-01-09
Start date
2019-12-26
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

N/A(healthy adults)

Interventions

Oral ingestion of the test food for 90 days

Sponsors

MORINAGA & CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Japanese individuals aged 20-64 years. 2) Individuals who are healthy and are not suffered from a chronic malady. 3) Individuals whose written informed consent has been obtained. 4) Individuals who can visit an inspection facility and be inspected in designated days. 5) Individuals judged appropriate for the study by the principal.

Exclusion criteria

Exclusion criteria: 1)Individuals using medical products. 2)Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung and blood disease. 3)Individuals who contract or have a history of serious gastrointestinal disease. 4)Individuals who have an addiction to alcohol or a mental illness. 5)Individuals who used or applied a drug for treatment of disease in the past 1 month. 6)Individuals with probable seasonal allergy, such as pollinosis, during the test period.(In particular, Betulaceae: alder, oba alnus firma, shirakaba, Taxodiaceae: cryptomeria, hinoki cypress, Asteraceae: ragweed, Artemisia vulgaris indica, Gramineae:Dactylis glomerata, Phleum pratense) 7)Individuals who have possibility of allergy symptoms onset by the test food and who cause severe allergic symptoms in foods and medicines. (In particular, gelatin, pork, apple, latex) 8)Individuals with serious anemia. 9)Individuals who are a smoker. 10)Females who are or are possibly pregnant, or are lactating. 11)Individuals whose life style will change during the test period. 12)Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. 13)Individuals who were hospitalized and received treatment in the past 6 months. 14)Individuals who participated in other clinical studies in the past 1 months or will participate in other clinical studies during the test period. 15)Individuals judged inappropriate for the study by the principal.

Design outcomes

Primary

MeasureTime frame
Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview 0 and 90 days after a test food intake

Countries

Japan

Contacts

Public ContactSadao Mori

MORINAGA & CO., LTD. Health Science and Research Center, R&D institute

s-mori-ab@morinaga.co.jp045-571-6140

Outcome results

None listed

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