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Investigation of the effect of the test food on immune functions, fecal odors, and fecal condition. -A placebo-controlled, randomized, double-blind clinical trial-

Investigation of the effect of the test food on immune functions, fecal odors, and fecal condition. -A placebo-controlled, randomized, double-blind clinical trial- - Investigation of the effect of the test food on immune functions, fecal odors, and fecal condition.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044037
Enrollment
40
Registered
2021-05-07
Start date
2021-06-12
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 adults

Interventions

Take 1 packet of the test food before sleeping once per day. Take 1 packet of the placebo food before sleeping once per day.

Sponsors

IMEQRD Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age between 40 and 70 years at the time of informed consent 2.Japanese male or female 3.Those who have contracted an upper respiratory infection every year. 4.Those who are able to input electronic diary with smartphone / PC 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 has been currently visiting a hospital or treated with any drug or herbal remedy (however, dosing as needed is allowed) for any disease. 2.On diet / exercise therapy under the guidance of a doctor 3.Have a current or history of serious illness 4.Those who have allergic dermatitis, (perennial/seasonal) 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 a current or previous history of drug and/or food allergies 7.Take lactic acid bacteria drinks, yogurt or supplements containing lactic acid bacteria daily. 8.Excessive consumption of alcohol (alcohol equivalent 60g or more / day) 9.Planning to significantly change their lifestyle (diet, sleep, exercise, etc.) during the trial. 10.Those who are planning travels to foreign countries during the trial period. 11.Irregular diet, shift worker, night shift, irregular life rhythm 12.Those who are currently pregnant or breastfeeding or those who want to become pregnant during the test period. 13.Participation in another clinical trial within one month of enrollment into the trial, participating currently or planning to participate. 14.Those who were determined by the investigator to be unsuitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Immunological markers Questionnaire for fecal conditions Questionnaire for physical conditions fecal condition markers (including fecal odors) gut microbiota

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