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

Effects of consumption of the test food on the immune function in healthy Japanese subjects: a randomized, double-blind, placebo-controlled trial - Effects of consumption of the test food on the immune function in healthy Japanese subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046464
Enrollment
200
Registered
2022-04-28
Start date
2022-01-04
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 subjects

Interventions

Duration: Eight weeks Test food: Active food Administration: Four capsules/pack/day * Daily dose should be taken in the morning. If you forget to take the test food, take it as soon as you rememb
t take it. Duration: Eight weeks Test food: Placebo food Administration: Four capsules/pack/day * Daily dose should be taken in the morning. If you forget to take the test food, take it as soon a
t take it.

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 or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects who have one or more days with common cold symptoms since five days before Scr 7. Subjects whose specific IgE (Japanese red-cedar, and cypress) are class zero *If the number of participants is less than planned, subjects in lower classes will be included. 8. Subjects whose physical fatigue are relatively large

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who have autoimmune disease 5. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily 6. Subjects who are taking immunosuppressants such as steroids 7. Subjects currently taking medicines (include herbal medicines) and supplements (particularly warfarin, sinus medication, and antihistamines) 8. Subjects who are allergic to medications and/or the test-food-related products 9. Subjects who are pregnant, breast-feeding, and planning to become pregnant 10. Subjects who have pollen allergy or perennial allergic rhinitis 11. Subjects who are smokers or have quit smoking within the last year before the agreement to participate in this trial 12. Subjects who suffer from COVID-19 13. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 14. Subjects who have received vaccination for influenza within the last three months before the agreement to participate in this trial 15. Subjects who are judged as ineligible to participate in the study by the physician 16. Subjects who drink alcoholic beverages excessively 17. Subjects who are on a diet 18. Subjects who have the erratic lifestyle because of shift work or other work

Design outcomes

Primary

MeasureTime frame
Common cold symptoms survey

Secondary

MeasureTime frame
Subjective quality of life (QOL) questionnaire

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