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Study on the gut environment by consumption of test meal in adult male and female subjects

Study on the gut environment by consumption of agarooligosaccharides in adult male and female subjects - Study on the gut environment by consumption of agarooligosaccharides in adult male and female subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056992
Enrollment
20
Registered
2025-02-10
Start date
2024-07-30
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 adult

Interventions

Consumption of test meal for 4 weeks

Sponsors

Ina Food Industry Co., Ltd.
Lead Sponsor
Fujita Health University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Individuals aged 20 to under 75 at the time of obtaining consent. (2)Individuals who do not have any gastrointestinal diseases and are deemed not to require immediate treatment. (3)Individuals who have received a thorough explanation of the study, can understand the content, and have provided their own consent.

Exclusion criteria

Exclusion criteria: (1)Individuals diagnosed with gastrointestinal diseases. (2)Individuals who may experience abdominal pain due to materials containing the involved ingredients. (3)Individuals who have undergone gastrointestinal surgery or require gastrointestinal surgery. (4)Individuals who regularly consume (three or more times a week) the involved ingredients, or have done so within the three months prior to the pre-test. (5)Individuals diagnosed with malignancies, or those undergoing treatment for neurological disorders, heart disease, kidney disease, diabetes, thyroid dysfunction, or those with a history of severe liver diseases. However, diseases deemed by the principal investigator to have no impact on this study's evaluation, such as treatment for hypertension, are excluded. (6)Individuals who consume large amounts of alcohol (equivalent to 60 g of alcohol per day: approximately 1500 mL of beer, 540 mL of wine, 3 go (about 540 mL) of sake, or 180 mL of whiskey). (7)Individuals who are at risk of developing allergies related to the test meal. (8)Individuals judged to be unsuitable as subjects based on responses to the lifestyle questionnaire. (9)Individuals who participated in another clinical study within one month prior to obtaining consent for this study, or those planning to participate in another clinical study after obtaining consent. (10)Other individuals deemed unsuitable as subjects by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Frequency of defecation and stool characteristics before and after 1, 2, 3 and 4 weeks of test meal consumption

Secondary

MeasureTime frame
Changes of intestinal microbiota and short-chain fatty acid concentrations at before and after 4weeks consumption

Countries

Japan

Contacts

Public ContactKoji Karasawa

Ina Food Industry Co., Ltd. Research and Development Department, Development Division

k-kouji@kantenpp.co.jp0265781121

Outcome results

None listed

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