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Examination of the effects of a test food on salivary IgA and gut microbiota

Examination of the effects of a test food on salivary IgA and gut microbiota - Examination of the effects of a test food on immune function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046416
Enrollment
30
Registered
2021-12-20
Start date
2022-01-08
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

Ingest a test food daily for 4 weeks

Sponsors

Healthcare Systems Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: [1] Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document [2] Healthy Japanese who are 20 years old or more and under 65 years old [3] Persons who are aware of constipation tendency (defecate 2 to 5 times / week)

Exclusion criteria

Exclusion criteria: [1] Persons who have chronic illness, receiving medication, have a serious disease history [2] Persons who are allergic to barley, wheat or rye [3] Persons who usually take a large amount of this test food [4] Persons who usually use pharmaceutical products and foods with health claims that may affect the intestinal environment and immunity [5] Persons who have participated in other studies within the first month before the start of this study, or persons who intend to participate in another study after consenting to this study [6] Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding [7] Persons who were judged as inappropriate for study participants by the principal investigator

Design outcomes

Primary

MeasureTime frame
Amount of salivary IgA(1) (1)0 and 4 weeks after the starts of intake

Secondary

MeasureTime frame
[1] Gut microbiota analysis(1) [2] Questionnaire on defecation status(2) [3] Questionnaire on cold symptoms(1) (1)0 and 4 weeks after the starts of intake (2)Daily 2 weeks before and 4 weeks during intake

Countries

Japan

Contacts

Public ContactYuki Asahina

Healthcare Systems Co., Ltd. Research and Development Department

asahina.yuki@hc-sys.jp03-6809-2722

Outcome results

None listed

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