Verification of the Comprehensive Health Effects Originating from the Gut Environment of the Test Food

Verification of the Comprehensive Health Effects Originating from the Gut Environment of the Test Food - Verification of the Comprehensive Health Effects Originating from the Gut Environment of the Test Food

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060262

Enrollment

Registered

2026-04-01

Start date

2026-05-11

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult

Interventions

Participants will freely consume the test food, an unprocessed food that has been eaten in Japan since ancient times, twice a day at home for four weeks. Participants will freely consume the placebo t

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Participants will be healthy adult women who understand the study's purpose and content and submit written informed consent before the start of the trial.

Exclusion criteria

Exclusion criteria: Individuals with barley or wheat allergies, as well as those who regularly use supplements or medications that may affect bowel movements, sleep, or mental health, will be excluded.

Design outcomes

Primary

Measure	Time frame
Gut microbiota after 4 weeks of test food intake.	—

Secondary

Measure	Time frame
Bowel Movement Survey, the Pittsburgh Sleep Quality Index (PSQI), the Patient Health Questionnaire-9 (PHQ-9), the MOS Short-Form 36-Item Health Survey (SF-36), cytokine levels, antibody titers	—

Countries

Japan

Contacts

Public ContactHONDA MARI

Kobe Women's University Department of Health, Sports, and Nutrition, Faculty of Health and Welfare

mhonda@kwjc.kobe-wu.ac.jp078-303-4700

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026