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A study for evaluating the safety of the intake of a test food for constipation tendency adults.

A study for evaluating the safety of the intake of a test food for constipation tendency adults. - A study for evaluating the safety of the intake of a test food.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030556
Enrollment
10
Registered
2018-01-14
Start date
2018-01-15
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

None

Interventions

Ingestion of a test food for 4 weeks.

Sponsors

TTC Co.,Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Healthy males and females aged 20-64 years. (2) Subjects with a tendency for constipation at around three to five times of defecation per week.

Exclusion criteria

Exclusion criteria: (1) Subjects who routinely use food rich in dietary fiber. (2) Subjects routinely taking medicine or health food which may influence bowel movement. (3) Subjects having a large amount of foods which may influence bowel movement such as food containing dietary fiber and lactic acid bacteria. (4) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative. (5) Subjects having diseases or a history of drug addiction or alcoholism. (6) Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease). (7) Subjects having possibilities for emerging allergy related to the study. (8) Subjects who are under medication or having a history of serious diseases for which medication was required. (9) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination. (10) 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. (11) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. (12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. (13) Subjects judged as unsuitable for the study by the investigator for other reasons.

Design outcomes

Primary

MeasureTime frame
Hematologic test Blood biochemistry test Urine analysis Blood pressure/pulsation Weight Doctor's questions Adverse event Intestinal flora

Countries

Japan

Contacts

Public ContactShingo Yamamichi

TTC Co.,Ltd Clinical Research Planning Department

s.yamamichi@ttc-tokyo.co.jp03-5459-5329

Outcome results

None listed

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