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Effects of consumption of the test food on immune function in healthy Japanese

Effects of consumption of the test food on immune function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study - Effects of consumption of the test food on immune function in healthy Japanese

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056125
Enrollment
180
Registered
2024-11-12
Start date
2024-11-12
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: Eight weeks The test food Administration: Four capsules/pack/day Duration: Eight weeks Placebo Administration: Four capsules/pack/day

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Male and female 3. Individuals aged 20 or more 4. Healthy individuals 5. Individuals who have had common cold-like symptoms at least once during the same period as this study's intervention in the past two years

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, anemia, or any other chronic diseases 4. Individuals who have autoimmune disease 5. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 6. Individuals who are taking or using medications (including herbal medicines) or supplements, particularly those who regularly use warfarin, rhinitis medicines, or antihistamines 7. Individuals who use immunosuppressants such as steroid 8. Individuals who are allergic to medicines or foods 9. Individuals who are pregnant, lactating, or planning to become pregnant during this study 10. Individuals who have pollen allergy or perennial allergic rhinitis 11. Individuals who are smokers or have quit smoking within the last year before the agreement to participate in this study 12. Individuals who drink alcoholic beverages excessively 13. Individuals who are on a diet 14. Individuals who engage in intense exercise 15. Individuals who have an irregular lifestyle due to shift work or other reasons 16. Individuals who have received vaccinations for the purpose of preventing infectious diseases within the three months before the agreement to participate in this study, or who are scheduled to receive vaccinations during this study 17. 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 18. Individuals who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

MeasureTime frame
Major immune related marker

Secondary

MeasureTime frame
<Important secondary outcomes> Physical condition questionnaire <Other secondary outcomes> Secondary immune related markers and quality of life (QOL) index

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