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A study to evaluate the effect of food ingredient in healthy adult on the immune system -Placebo-controlled, randomized, double-blind, parallel-group comparative method

A study to evaluate the effect of food ingredient in healthy adult on the immune system -Placebo-controlled, randomized, double-blind, parallel-group comparative method - A study to evaluate the effect of food ingredient in healthy adult on the immune system -Placebo-controlled, randomized, double-blind, parallel-group comparative method

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045838
Enrollment
100
Registered
2021-10-22
Start date
2021-11-28
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 adult

Interventions

Sponsors

CPCC Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy males and females from 20 to 64 years of age (2) Subjects who are aware that they are susceptible to cold and flu (3) Subjects who have gotten corona virus vaccination twice at least 14 days prior to the date of obtaining consent (3) Subjects who have received sufficient explanation of this study, understands the contents, and are able to give written consent

Exclusion criteria

Exclusion criteria: (1) Subjects who regularly intake food containing involvement ingredients at least 3 times a week. (2) Subjects who constantly use supplements or drugs affecting the immune system. (3) Subjects who regularly intake food or medicines rich in lactic acid bacteria at least 3 times a week (4) Subjects who undergoing treatment affecting the outcome of the study (5) Night and day shift worker or manual laborer (6) Subjects who are habitually vigorous exercise such as marathon (7) Subjects who cannot carry out the inspection procedure of various inspection by the rule during the study period (8) Subjects are undergoing medical treatment or judged as require medical treatment (9) Subjects who have under treatment or a history of serious disease (10) Subjects who are pregnant, lactating, or intending to become pregnant during the study period (11) Subjects who are allergic to medicines and foods (12) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (13) Subjects who are participating in other clinical trials of drug or health food, or within 4 weeks of completion of the trial, or who plan to participate in other clinical trials after agreeing to participate in the study (14) Subjects who have donated 200 mL component blood or whole blood for 1 month prior to the study (15) Men who have donated 400 mL whole blood for 3 months prior to the study (16) Women who have donated 400 mL of whole blood for 4 months prior to the study (17) Men who have donated more than 1,200 mL of blood in the 12 months prior to the study, by adding the total planned blood collection volume for the study (18) Women who have donated more than 800 mL of whole blood in the 12 months prior to the study, by adding the total planned blood volume for the study. (19) Subjects who are judged as unsuitable for the study by the principal investigator

Design outcomes

Primary

MeasureTime frame
Immune function

Secondary

MeasureTime frame
Physical condition questionnaire

Countries

Japan

Contacts

Public ContactTomomi Tanaka

Kewpie Corporation R&D Division

tomomi_tanaka@kewpie.co.jp03-5384-7759

Outcome results

None listed

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