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Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with pre- constipation subjects

Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with pre- constipation subjects - Safety evaluation studies of long-term consumption of food containing resistant glucan (water-soluble dietary fiber) in healthy subjects or subjects with pre- constipation subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018529
Enrollment
20
Registered
2015-08-07
Start date
2015-08-08
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

Sponsors

TTC Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy adult males and females from 20 to 64 years of age (2) Subjects falling under any of the following A. 10 subjects whose normal stool frequency is around 3-5 times per week B. 10 subjects whose normal stool frequency is around 7 times per week

Exclusion criteria

Exclusion criteria: (1) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative (2) Subjects currently undergoing treatment with digestive diseases that affect the study or having a surgical history of digestive system (except appendicectomy) (3) Subjects having diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement or a history of these diseases (4) Subjects having a disease requiring treatment or a history of serious diseases, diabetes, hepatopathy, renal or heart disease (5) Subjects having possibilities for emerging allergy related to the study (6) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (8) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (9) Subjects who intend to become pregnant or lactating (10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (11) Subjects judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Adverse event

Countries

Japan

Contacts

Public ContactYuki Kitahara

TTC Co.,Ltd. Clinical Research Planning Department

y.kitahara@ttc-tokyo.co.jp03-5459-5329

Outcome results

None listed

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