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An exploratory study on the effect of continuous intake of test foods on the immune system. -a randomized, placebo-controlled, double-blind, parallel-group comparison trial-

An exploratory study on the effect of continuous intake of test foods on the immune system. -a randomized, placebo-controlled, double-blind, parallel-group comparison trial- - An exploratory study on the effect of continuous intake of test foods on the immune system.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046190
Enrollment
24
Registered
2022-12-27
Start date
2022-01-27
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 two capsules of the placebo food after breakfast once every day. Take two capsules of the test food after breakfast once every day.

Sponsors

IMEQRD Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged between 50 and less than 65 years old. 2. Japanese males and females. 3. Individuals who contract the common cold between winter and spring every year. 4. BMI between 17.5 kg/m^2 and less than 30.0 kg/m^2. 5. Individuals who can use smartphones or PCs to input an electronic diary. 6. Individuals who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.

Exclusion criteria

Exclusion criteria: 1. Individuals who have mouth dryness, or hypersalivation. 2. Individuals who are currently undergoing treatment for any disease with medical drugs or traditional Chinese medicines. However, medications used as needed will be allowed to join the trial. 3. Individuals who are managed by medical doctors for diet therapy and exercise therapy. 4. Individuals who have severe diseases or a history of severe diseases. 5. Individuals who have allergic dermatitis, allergic rhinitis, bronchial asthma, or chronic bronchitis. 6. Individuals who have been taking yogurts or beverages, which include Lactic acid bacteria and/or Bifidobacterium. 7. Individuals who have currently been taking commercially available drugs, quasi-drug products, and foods or supplements with functional claims. 8. Individuals who have a drug allergy, or a food allergy. 9. Individuals who work in shift, night shift, and marked irregular work in shift. 10. Individuals who are planning extremely change their lifestyle (such as diet, sleep, or exercise) during the trial period. 11. Individuals who drink more than 60 g alcohol/day. 12. Individuals who have been vaccinated to protect against infectious disease one month before the screening period. Also, individuals who are planning vaccination during the trial period. 13. Individuals who are planning travel to foreign countries during the trial period. 14. Individuals who joined other clinical trials from 1 month before obtaining informed consent in this trial, or individuals who have currently been joined other clinical trials. Also, individuals who are planning to join other clinical trials. 15. Individuals who donated blood more than 200 mL within one month before, or more than 400 mL within three months before the screening period. 16. Individuals who cannot discontinue taking any alcoholic drinks two days before the date of visit. 17. Individuals who are unsuitable for this trial, that judged by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Immune function-related biomarkers Physical condition questionnaire QoL questionnaire

Countries

Japan

Contacts

Public ContactYoshitada Hira

IMEQRD Co, Ltd. Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

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