A verification study to evaluate the safety of long-term consumption of the test food

A verification study to evaluate the safety of long-term consumption of the test food: a randomized, placebo-controlled, double-blind, parallel-group comparison study - A verification study to evaluate the safety of long-term consumption of the test food

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000055038

Enrollment

Registered

2025-12-22

Start date

2024-07-22

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 Japanese

Interventions

Duration: 12 weeks Test food: Lactic acid bacteria powder Duration: 12 weeks Test food: Hydrolysate of rice protein Duration: 12 weeks Test food: Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Healthy individuals 4. Individuals aged 20 or more and less than 70

Exclusion criteria

Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines or foods related to test products 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 9. Individuals who are planning to undergo gastrointestinal surgery or colonoscopy 10. Individuals who are undergoing medical treatment for immunodeficiency disorders 11. Individuals who are suffering from valvular heart disease 12. Individuals who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

Measure	Time frame
1. Individuals who experienced adverse events	—

Secondary

Measure	Time frame
1. Physical measurements, physical examination, urine test, peripheral blood test	—

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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