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Investigation of the effects of test-food consumption on the gut environment

Investigation of the effects of test-food consumption on the gut environment - Investigation of the effects of test-food consumption on the gut environment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054619
Enrollment
39
Registered
2025-05-20
Start date
2024-06-12
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 Japanese

Interventions

Consumption of test food 1 for 4 weeks Consumption of test food 2 for 4 weeks Consumption of placebo for 4 weeks

Sponsors

Asahi Group Foods, Ltd.
Lead Sponsor
Metagen, Inc.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. At informed consent, male/female subjects aged more than or equal to 20, and less than 65 years old 2. Subjects who defecate at least 3 times per week 3. Subjects who can show their understanding of the study procedure and agreement with participating in the study by written informed consent prior to the study

Exclusion criteria

Exclusion criteria: 1. Subjects who regularly consume foods for specified health uses, foods with function claims, supplement and/or health foods, which would affect the trial results for more than 3 times a week, and who are unable to discontinue consumption from the day of the preliminary test 2. Subjects who have taken medications that would affect the study (e.g., bowel preparation, laxatives, etc.) for one month prior to the start of consumption of the test food, and who are unable to limit the use of such medications during the study period 3. Subjects who have taken antibiotics affecting the study for more than 2 months prior to the intervention period, and who cannot limit their use during the study period 4. Subjects who are currently undergoing other clinical trials with any kind of medicine/food, or who have participated in such trials within a month before this trial, or who will participate in such trials after giving informed consent to participate in this trial 5. Subjects with irregular dietary habits 6. Subjects who are expected to undergo major changes in their living environment, such as home and/or work, during this trial 7. Subjects whose roomer is planning to join this trial 8. Subjects who are smoker 9. Subjects who take excessive alcohol, defined as "drinkers whose average weekly alcohol intake exceeds 60 grams/day" 10. Subjects who had undergone appendectomy 11. Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent 12. Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases 13. Pregnant, possibly pregnant, or lactating women 14. Subjects who are allergic to medicines and/or foods 15. Others who have been determined ineligible by the study representative

Design outcomes

Primary

MeasureTime frame
Fecal short-chain fatty acids

Secondary

MeasureTime frame
1. Fecal microbiota 2. The status of defecation

Countries

Japan

Contacts

Public ContactMisaki Hatanaka

Asahi Group Foods, Ltd. Technology Research&Development Department 1

misaki.hatanaka@asahi-gf.co.jp0570-00-5112

Outcome results

None listed

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