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A study on the effect of the test food on immunological functions on healthy adults. -A placebo-controlled, randomized, double-blind clinical trial-

A study on the effect of the test food on immunological functions on healthy adults. -A placebo-controlled, randomized, double-blind clinical trial- - A study on the effect of the test food on immunological functions on healthy adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044768
Enrollment
80
Registered
2021-11-11
Start date
2021-09-13
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 2 tablets the test food once a day with water or warm water after breakfast. Take 2 tablets a placebo food once a day with water or warm water after breakfast.

Sponsors

IMEQRD Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged between 30 and 70 years. 2. Japanese male or female. 3. Those who are susceptible to upper respiratory disease. 4. Those who can use smartphones or PCs to input an electronic diary. 5. Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent.

Exclusion criteria

Exclusion criteria: 1. Those who are currently undergoing treatment for any disease. Also, those who receive medical treatments from medical doctors via drugs or traditional Chinese medicines. 2. Those who receive diet or exercise therapies by doctors. 3. Those who have severe diseases or history of severe diseases. 4. Those who have allergic dermatitis, allergic rhinitis, bronchial asthma, and chronic bronchitis. 5. Those who have currently been taking drugs, quasi-drug products, and foods or supplements which have health claims. However, those who can discontinue taking these materials during the trial period after obtaining informed consent will be allowed to join the trial. 6. Those who have currently been taking yogurts or beverages, which include Lactobacillus and/or Bifidobacterium for being healthy. However, those who can discontinue taking these foods during the trial period after obtaining informed consent will be allowed to join the trial. 7. Those who received the vaccination against SARS-CoV2 after May 2021. Also, those who receive the vaccination during the trial period. 8. Those who have a drug allergy or a food allergy. 9. Those who work on the night shift and the shiftwork. 10. Heavy drinkers who drink over 60 g alcohol/day. 11. Those who have a smoking habit (over 21 cigarettes/day). 12. Those who are planning extremely change their lifestyle (such as diet, sleep, or exercise) during the trial period. 13. Those who are currently pregnant or breastfeeding, or those who are planning to pregnant during the trial period. 14. Those who are planning travels to foreign countries during the trial period. 15. Those who joined other clinical trials from 1 month before obtaining informed consent in this trial, or those who have currently been joined other clinical trials. Also, those who are planning to join other clinical trials. 16. Those who are unsuitable for this trial that judged by the principal investigator.

Design outcomes

Primary

MeasureTime frame
A subjective questionnaire for physical condition

Secondary

MeasureTime frame
Immune markers (TNFa, IFNg, IL6, IL4 and IL1b levels in blood, and cytotoxic activity of NK cells)

Countries

Japan

Contacts

Public ContactHirokuni Kayama

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