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Verification of the effect of test food on the intestinal environment

Verification of the effect of test food on the intestinal environment - Verification of the effect of test food on the intestinal environment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000053197
Enrollment
10
Registered
2024-01-24
Start date
2024-01-24
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

non-handicapped person

Interventions

Test food (2 weeks) to Washout period (2 weeks) to Placebo (2 weeks) Placebo (2 weeks) to Washout period (2 weeks) to Test food (2 weeks)

Sponsors

Fuji Nihon Seito Corporation
Lead Sponsor
Faculty of Agriculture,Kyushu University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Japanese national whose native language is Japanese (2) Age at the time of measurement must be between 20 and 60 years old. (3) Constipation tendency (average of 3 to 5 bowel movements per week) However, the defecation status up to the time of screening should be confirmed in the Defecation diary, and subjects should be selected. (4) BMI 18.5 to 25

Exclusion criteria

Exclusion criteria: (1)Those who have a bowel movement every day (2)Those who are receiving treatment (including medication) for some disease at a medical institution (3)Those who have a current or previous serious disease (4)Those who are taking intestinal regulators or laxatives on a daily basis. (5)Those who routinely consume food for specified health use, functional foods, yogurt, or lactic acid bacteria beverages that are thought to be involved in intestinal regulation. (6)Those who habitually take supplements or nutrient-fortified foods on a daily basis (7)Those who have drug allergy or food allergy or have a history of such allergy.(Those who are at risk of developing allergic symptoms to the test food) (8)Those who have participated or are currently participating in other clinical trials within 1 month of obtaining consent, or those who plan to participate during the study period (9)Those who have an irregular rhythm of life, such as shift work, late-night work, etc. (10)Those who drink a lot of alcohol on a daily basis (alcohol equivalent to 60g/day) (11)Smoking (12)Patients who are judged to be inappropriate for this study by the investigator. (13)BMI less than 18.5 or greater than 25

Design outcomes

Primary

MeasureTime frame
intestinal microflora

Secondary

MeasureTime frame
VAS Blood short-chain fatty acids EEG

Countries

Japan

Contacts

Public ContactHitomi Miyazaki

Faculty of Agriculture,Kyushu University Laboratory of Systematic Forest and Forest Products Science

miyazaki.hitomi.309@m.kyushu-u.ac.jp092-553-9458

Outcome results

None listed

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