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A study of changes in the gut microbiota after continuous consumption of foods rich in fermentable dietary fiber in human

A study of changes in the gut microbiota after continuous consumption of foods rich in fermentable dietary fiber in human: a randomized, placebo-controlled, double-blind, parallel-group comparison study - A study of changes in the gut microbiota after continuous consumption of foods rich in fermentable dietary fiber in human

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054712
Enrollment
100
Registered
2025-04-30
Start date
2024-06-19
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 Japanese

Interventions

Duration: Four weeks Test food: Food rich in fermentable dietary fiber Duration: Four weeks Test food: General food low in fermentable dietary fiber

Sponsors

ORTHOMEDICO Inc.
Lead Sponsor
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese 2. Men or women 3. Individuals aged 20 or more and less than 50 4. Healthy individuals 5. Individuals whose defecation frequency for a week prior to screening is four times or more and ten times or less

Exclusion criteria

Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) and supplements (particularly antibiotic or gastric acid secretion inhibitors) 6. Individuals who are allergic to medicines and/or the test product related products (particularly wheat, eggs, milk, soybeans, chicken, pork, gelatin, seafood, buckwheat, Japanese yam, almonds, orange, and/or peach) 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 9. Individuals who took dietary fiber as a health food (rich in fiber such as inulin, oligosaccharide, resistant dextrin, easy fiber, sun fiber, or burdock tea) within the last month 10. Individuals who are judged as ineligible to participate in this study by the physician

Design outcomes

Primary

MeasureTime frame
Analysis of the effect on changes in intestinal environment with continuous consumption of foods rich in fermentable dietary fiber in healthy adults

Countries

Japan

Contacts

Public ContactNaoko Suzuki

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

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