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Comparison of the efficacy of dietary fiber-containing food on gastrointestinal condition : a double blind, randomized , crossover study

Comparison of the efficacy of dietary fiber-containing food on gastrointestinal condition : a double blind, randomized , crossover study - Comparison of the efficacy of dietary fiber-containing food on gastrointestinal condition

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000037865
Enrollment
30
Registered
2019-09-01
Start date
2019-10-20
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

Washout period for 14 days -&gt
Taking a test food A for 14 days -&gt
Taking a test food B for 14 days Taking a control food for 14 days -&gt
Taking a test food B for 14 days -&gt
Taking a test food A for 14 days

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Healthy males and females from 20 to 60 years old 2)Subjects with defecation at three to five times per week 3) Usually eat three meals a day 4)Subjects who have received written informed consent

Exclusion criteria

Exclusion criteria: 1) Subjects who regularly use laxatives 2) Subjects who regularly take foods which may affect gastrointestinal condition at the screening period 3) Subjects who regularly use antibiotics and other medicines which affect digestion and absorption at the screening period and taking control food period 4) Subjects who cannot abstain from taking foods which are containing viable bacteria, enriched with oligosaccharides or dietary fiber, considered effective for constipation improvement and are containing large amount of sugar alcohol 5) Subjects who have allergy for foods 6) Subjects who regularly take too much alcohol(more than 60g/day as a pure alcohol for 5 days or more) 7) Subjects who have diseases which require urgent treatment or severe complications 8)Subjects who have gastrointestinal diseases or a surgical history which may affect digestion, absorption and defecation 9)Subjects who are judged to be inappropriate for the study from the answers to the background questionnaire 10) Subjects who are pregnant, lactating or planning to be pregnant in the test period 11) Subjects who are under treatment or have a history of drug addiction or alcoholism 12) Subjects who are participating or planning to participate in a clinical study 13) Subjects who are judged as inappropriate by investigator

Design outcomes

Primary

MeasureTime frame
Defecation frequency

Secondary

MeasureTime frame
Defecation days, stool volume, stool shape, stool color, stool smell and the feeling after defecation

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales department

yoshi@kso.co.jp03-3452-7733

Outcome results

None listed

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