Skip to content

Research on the functional and safety assessment of test food intake

Research on the functional and safety assessment of test food intake : Open-label study - Research on the functional and safety assessment of test food intake : Open-label study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059050
Enrollment
20
Registered
2025-09-17
Start date
2025-09-18
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 elementary school student

Interventions

Intake of test food for 8 consecutive weeks

Sponsors

Miura Clinic, Medical Corporation Kanonkai
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy elementary school students (1st to 6th grades: excluding menstrual periods) (2) Subjects whose parents or legal guardians (hereinafter referred to as 'guardians') received a full explanation of the purpose and content of the study, fully understood it, and voluntarily provided written informed consent for the subject's participation in the study

Exclusion criteria

Exclusion criteria: (1) Subjects with a history of mental illness, diabetes, liver diseases, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious disease. (2) Subjects who have undergone gastrointestinal surgery. (3) Subjects showing abnormal liver and kidney function test values. (4) Subjects with a current medical condition. (excluding cavity treatment) (5) Subjects who are allergic to food and drugs. (6) Subjects who participate in strenuous sports and subjects who are trying to lose weight. (7) Subjects with extremely irregular eating habits. (8) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the study period. (9) Subjects who are continuously treated with medications (including OTC, prescription drugs). (10) Subjects who are currently participating in other clinical studies or are scheduled to participate in research at the start of this study. (11) Other subjects judged by the investigator or the investigator to be inappropriate for the examination.

Design outcomes

Primary

MeasureTime frame
Diary

Secondary

MeasureTime frame
Medical examination s-IgA in saliva Height measurement Blood pressure Inbody (weight, muscle mass) Brief-type Diet History Questionnaire for 15-year-old

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 3, 2026