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A study to confirm the safety of overdose of test food: a randomized, double-blind, placebo-controlled trial.

A study to confirm the safety of overdose of test food: a randomized, double-blind, placebo-controlled trial. - A study to confirm the safety of overdose of test food.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049913
Enrollment
30
Registered
2022-12-27
Start date
2018-08-20
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

Take 10 capsules of the test food once a day around 10:00 am for 4 weeks. Take 5 capsules of the test food and 5 capsules of the control food once a day around 10:00 am for 4 weeks. Take 10 capsules o

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Males and females from 20 to 64 years of age. 2. Subjects who can make self-judgment and are voluntarily giving written informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects who have a history of Serious diseases such as diabetes, kidney/liver disease or heart disease, and/or thyroid diseases, adrenal diseases, and other metabolic diseases or who is under medical treatment. 2. Subjects who have chronic disease and is under medication. 3. Subjects who have a history of gastrointestinal disease or gastrointestinal surgery that affects digestion and absorption. 4. Subjects who have a history of drug dependence or alcohol dependence or have a current medical history. 5. Those who consistently drink more than the recommended amount of alcohol. 6. Subjects who cannot abstain from drinking 2 days before each test. 7. Subjects who has food allergy. 8. Subjects who are judged to be inappropriate as research subjects by blood tests in screening tests. 9. Subjects who has collected or donated more than 200 mL of blood or blood components within 1 month or more than 400 mL of blood or blood within 3 months prior to the date of obtaining consent. 10. Subjects who are participating in other studies that using foods, pharmaceuticals, and cosmetics now, or are willing to participate. 11. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period. 12. Subjects who are judged as unsuitable for the study by the investigator for the other reasons.

Design outcomes

Primary

MeasureTime frame
1. Medical interview 2. Height / weight (BMI) 3. Blood pressure / Pulse rate 4. Hematology test 5. biochemical test 6. Urinalysis 7. Subjective and Objective symptom 8. Adverse event

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

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