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Verification research for the minimum effectiveness of the test food

Verification research for the minimum effectiveness of the test food - Verification research for the minimum effectiveness of the test food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058789
Enrollment
20
Registered
2025-08-13
Start date
2025-01-01
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 Adults

Interventions

Intake 4 g of test food every day for 4 weeks.

Sponsors

BIOSIS Lab. Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Persons who are aged 18 to 100 at the time of consent, both men and women 2. Persons who are not suffering from intestinal diseases (including those who are judged not to require immediate treatment) 3. Persons who received a sufficient explanation of the purpose and contents of the research, have the capacity to consent

Exclusion criteria

Exclusion criteria: 1. Persons who may experience abdominal pain when eating ingredients containing dietary fiber, such as Barley Max 2. Persons who have been diagnosed with a digestive disease, previously undergone digestive surgery, and will require digestive surgery in the future 3. Persons who regularly use (at least 3 days a week) ingredients containing ingredients containing dietary fiber, such as Barley Max, or have regularly used within the 3 months prior to the pre-test 4. Persons who have been diagnosed with malignant tumors, currently receiving treatment for cranial nerve, heart, kidney, diabetes, or thyroid dysfunction, and with a history of serious illnesses such as liver disease, excluding illnesses like hypertension, which the principal investigator determined will not affect the evaluation of the research. 5. Persons who drink a large amount of alcohol (60 g or more of alcohol per day: approximately 1500 mL of beer, 540 mL of wine, 3 cups of sake, or 180 mL of double-sized whiskey) 6. Persons who are at risk of developing allergies related to the test food, such as those with wheat or barley allergies 7. Persons who are judged unsuitable as research subjects based on their responses to a background survey 8. Persons who have participated in other research during one month prior to the start of this research, or plan to participate in other research after consenting to this research. 9. Persons who are judged to be ineligible by the principal investigator

Design outcomes

Primary

MeasureTime frame
Fecal bacterial flora

Secondary

MeasureTime frame
Questionnaire, learning effect

Countries

Japan

Contacts

Public ContactTakumi Tochio

BIOSIS Lab. Co., Ltd. CEO

takumitochiobiz@gmail.com090-6904-6772

Outcome results

None listed

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