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Efficacy Test for Immune Function by Daily Ingestion of Test Food: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

Efficacy Test for Immune Function by Daily Ingestion of Test Food: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study - Efficacy Test for Immune Function by Daily Ingestion of Test Food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043856
Enrollment
24
Registered
2021-04-07
Start date
2021-05-14
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

Daily ingestion of 4 capsules of test food for 12 weeks. Daily ingestion of 4 capsules of dextrin for 12 weeks.

Sponsors

Hokkaido Information University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent. 2.Subjects with relatively low NK cell activity.

Exclusion criteria

Exclusion criteria: 1.Subjects who are under treatment or medication for autoimmune diseases, chronic inflammatory diseases, allergies, thrombocytopenia, and hypertension. 2.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 3.Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 4.Subjects with unusually high and/or low blood pressure and/or abnormal physical data and hematological data. 5.Subjects with severe anemia. 6.Pre- or post-menopausal women complaining of obvious physical changes. 7.Subjects who are at risk of having allergic reactions to drugs or foods (especially mushrooms). 8.Subjects who regularly take medicines, functional foods, and/or supplements which would affect the immune function. 9.Heavy smokers, alcohol addicts or subjects with disordered lifestyle. 10.Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study. 11.Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 12.Subjects determined to be ineligible by the principal investigator.

Design outcomes

Primary

MeasureTime frame
NK cell activity at 4, 8, and 12 weeks after beginning the intake of test food.

Secondary

MeasureTime frame
IFN-gamma, the Brief Job Stress Questionnaire (Section B).

Countries

Japan

Contacts

Public ContactNaoyuki HONMA

Hokkaido Information University Health Information Science Center

hisc-acad.res@s.do-johodai.ac.jp011-385-4430

Outcome results

None listed

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