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Investigation of the effect of test food on the intestinal barrier

Investigation of the effect of test food on the intestinal barrier - Investigation of the effect of test food on the intestinal barrier

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048679
Enrollment
60
Registered
2023-04-01
Start date
2022-08-27
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 volunteers

Interventions

Intake of test food for 8 weeks Control (No treatment)

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Males and females aged more than or equal to 20, and less than 75 when obtaining the consent 2. Subjects whose BMI is 18.5 or more and less than 30 3. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the present study and being able to sign a written informed consent

Exclusion criteria

Exclusion criteria: 1. Subjects who have been reported to have galactosemia 2. Subjects who have history of gastrointestinal surgical procedures 3. Subjects who take food or supplement which have the possibility to affect the results of the present study more than 4 days a week before 2 months of informed consent 4. Subjects who can't restrict food or supplement which have the possibility to affect the results of the present study from the observation period to the present study period 5. Subjects who take medications that may affect bowel symptoms or non-steroidal anti-inflammatory drugs such as aspirin more than 3 days a week before 1 months of informed consent 6. Subjects who have taken antibiotics before 2 months of informed consent 7. Subjects who can't restrict taking OTC drugs, quasi-drugs, supplements, or health foods from the day before the examination until the completion of the examination 8. Subjects who are expected to undergo a major change in their home, work, or other living environment during the research period 9. Subjects who are smokers 10. Subjects who have abdominal symptoms by ingesting dairy products 11. Subjects with food allergies 12. Subjects who are pregnant or lactating, or intending to become pregnant during the study 13. Subjects who had participated in other clinical trials within the past month 14. Subjects suffering from or undergoing treatment for diabetes, digestive diseases, heart disease, thyroid disease, adrenal disease, and other metabolic diseases 15. Subjects who tested positive for hepatitis B virus or hepatitis C virus in the screening 16. Subjects deemed unsuitable for the present study by the investigator

Design outcomes

Primary

MeasureTime frame
Intestinal barrier index

Secondary

MeasureTime frame
Blood/fecal tests Subjective symptoms

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

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