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A study for the effect of test food on infectious diseases in selected community. A randomized, double-blind, placebo-controlled, parallel-group comparison trial.

A study for the effect of test food on biological response of infectious diseases in selected community. A randomized, double-blind, placebo-controlled, parallel-group comparison trial. - A study for the effect of test food on infectious diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000053690
Enrollment
110
Registered
2024-03-01
Start date
2023-11-29
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

None (Healthy adult)

Interventions

Daily one bottle of study product is administered to participant for consecutive 4 weeks. Daily one bottle of placebo is administered to participant for consecutive 4 weeks.

Sponsors

National Institute of Nutrition
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Signed and dated informed consent form provided, after willingness of participants confirmed 2)Willingness to comply with all study procedures for the period of the study 3)Healthy adult (20 < Age < 30) 4)Persons who have COVID vaccine at least two times and more than 2 weeks have passed after last vaccination 5)Persons who are not currently infected with SARS-CoV2, and if they had been infected, at least 4 weeks have passed since recovery. 6)No underlying acute and/or chronic sickness from respiratory disease and/or gastrointestinal disease at enrolment.

Exclusion criteria

Exclusion criteria: 1)Unable to provide signed and dated informed consent form 2)Unable to comply with all the study procedures 3)Allergic to milk and/or soy (contained within the study products) 4)Regularly using steroid drugs (immune suppressive drugs) 5)Any persons deemed inappropriate as participants by the principal investigators of this study 6)Those currently participating in other clinical trials (participants) or those who are planning to participate in other clinical trials during the study period 7)Women who are pregnant, or intend to get pregnant during the study period, or breastfeeding mothers 8)Cannot stop drinking alcohol for two days before sampling blood

Design outcomes

Primary

MeasureTime frame
The effect of test food on biological response of infectious diseases on biological response of blood cells.

Secondary

MeasureTime frame
1. General wellbeing of participants evaluated by questionnaires. 2. Severity of infectious disease like illness 3. Expression of anti-infectious factors

Countries

Asia(except Japan)

Contacts

Public ContactHajjime Nozawa

Kirin Holdings Co., Ltd. Institute of health science

h-nozawa@kirin.co.jp+818022893085

Outcome results

None listed

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