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Evaluation of the effect of test food intake on the gut environment

Evaluation of the effect of test food intake on the gut environment - Evaluation of the effect of test food intake on the gut environment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000053235
Enrollment
12
Registered
2024-12-26
Start date
2023-12-26
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 male/female adults

Interventions

Consumption of the test food 1 (1 pack a day, 4 weeks) -&gt
Consumption of the test food 2 (1 pack a day, 4 weeks)

Sponsors

Metagen, Inc.
Lead Sponsor

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 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 use foods that explicitly contain tamarind seed gum as a food additive and have been unable to discontinue them since the time of obtaining consent. (2) Subjects who are taking food for specified health use, foods with functional claims, or health foods (including supplements) that may affect the study at least three times a week and are unable to maintain the amount and frequency of intake during the study period. (3) Subjects who are taking medicines (antibiotics, bowel regulators, antidiarrheals, laxatives) at least once a week that could potentially affect the study and whose medication cannot be restricted during the study period (no medication, but eye and nose drops are allowed) (4) Subjects who are now under other clinical tests with some kind of medicine/food, or participated in those within a month before this trial, or will join those after giving informed consent to participate in this trial. (5) Subjects who have previous/current medical history of illnesses related to immunity, such as autoimmune diseases, or gastrointestinal diseases. (6) Pregnant, possibly pregnant, or lactating women. (7) Subjects who are allergic to medicines and test foods (tamarind seed gum). (8) Others who have been determined ineligible by the principal/sub investigator.

Design outcomes

Primary

MeasureTime frame
VAS (fatigue)

Secondary

MeasureTime frame
- Intestinal barrier - Gut microbiota - Gut metabolites - Defecation status - POMS2

Countries

Japan

Contacts

Public ContactYumewo Suzuki

MP Gokyo Food & Chemical Co., Ltd. Planning & Coordination / Research, Development & Technology

yumeo.suzuki@mpgfc.co.jp06-7177-6866

Outcome results

None listed

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