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Safety evaluation

Safety evaluation of excessive intake of food containing test foods for healthy adults - Safety evaluation of excessive intake of food containing test foods

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038002
Enrollment
20
Registered
2019-09-12
Start date
2019-09-13
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 adult

Interventions

Intake of 0.85 g of test food per day for 4 consecutive weeks Intake of 4.25 g of test food per day for 4 consecutive weeks

Sponsors

TTC Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Males and females from 20 to 64 years of age

Exclusion criteria

Exclusion criteria: (1) Subjects who constantly use health food richly containing involvement ingredient (2) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (4) Who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (5) Subjects having possibilities for emerging allergy related to the study (6) Those with diseases that require constant medication or a history of serious diseases for which medication was required (7) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (8) Subjects who intend to become pregnant or lactating (9) Subjects judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Physical, Hematologic, Blood biochemical, Urinalysis, Doctor's questions, Weight before and 2,4 weeks after intake and 2 weeks after the end of intake period and Adverse events through the study

Countries

Japan

Contacts

Public ContactYuka Sato

TTC Co., Ltd. Clinical Research Planning Department

y.sato@ttc-tokyo.co.jp03-5459-5329

Outcome results

None listed

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