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Verification of the efficacy study of test food

Verification of the efficacy study of test food : Placebo-controlled, double-blind, randomized, parallel-group comparison study - Verification of the efficacy study of test food : Placebo-controlled, double-blind, randomized, parallel-group comparison study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055309
Enrollment
45
Registered
2024-08-28
Start date
2024-09-24
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 1 for 8 weeks Ingestion of test food 2 for 8 weeks Ingestion of placebo food for 8 weeks

Sponsors

Miura Clinic, Medical Corporation Kanonkai
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Subjects of men and women aged 20 to 49 (2) Subject feeling tired (3) Subjects who do not have allergic symptoms (cedar, cypress) during the test period (4) Subjects who are vulnerable to colds and influenza as a consciousness (5) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.

Exclusion criteria

Exclusion criteria: (1) Subjects with a history of 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 with abnormal liver and renal function test values (4) Subjects with diseases currently being treated (5) Subjects using immunosuppressive agents such as steroids (6) Subjects who are allergic to food and drugs (7) Subjects with anemia symptoms (8) Female subjects wishing to become pregnant while participating in this study, pregnant (including those who may be pregnant) or lactating female subjects (9) Subjects who play intense sports and subjects who are on a diet (10)Subjects with extremely irregular eating habits s (11)Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (12)Subjects who are continuously treated with pharmaceuticals (including OTC and prescription drugs) (13)Subjects who drink more than 40 g of pure alcohol per day for males and 20g of pure alcohol per day for females (14)Subjects with smoking habits (15)Subjects with irregular lives such as shift workers (16)Subjects who are participating in or will participate in other clinical trials at the start of this study (17)Other subjects judged by the investigator or the investigator to be inappropriate for the examination

Design outcomes

Primary

MeasureTime frame
Immune cells Activity Cold symptoms score Visual Analogue Scale

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