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A verification study of influence on defecation by consumption of the polydextrose-containing food for adult male and female with constipation tendency

A verification study of influence on defecation by consumption of the polydextrose-containing food for adult male and female with constipation tendency - Verification of influence on defecation by consumption of the polydextrose-containing food

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025944
Enrollment
90
Registered
2017-02-05
Start date
2017-02-06
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

Intake 2 packs of test food in a day at any time for 2 weeks. Keep interval minimum 6 hrs between test foods intake. Intake 2 packs of control food in a day at any time for 2 weeks. Keep interval min

Sponsors

CPCC Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Males and females aged 20 to 59 years old. (2) Subjects who defecate 2 to 4 times in a week. (3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.

Exclusion criteria

Exclusion criteria: (1)Subjects who are diagnosed as a strong constipation by a doctor. (2)Subjects who are diagnosed with diabetes (including boundary type) by a doctor. (3)Subjects who regularly use medical drugs and/or supplements that have bowel movement improving effect. (4)Pregnant or expected pregnant women, or lactating women. (5)Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney and/or digestive trucks. (6)Subjects who excessive alcohol intake. (7)Subjects who have extremely irregular life rhythm, and subjects who have midnight work or irregular shift work. (8)Subjects who have previous medical history of drug and/or food allergy. (9)Subjects who are participating the other clinical tests of medicines or foods. Subjects who participated other clinical tests of medicines or foods within 4-weeks prior to the current study. Subjects who are planning to participate in other clinical tests of medicines or foods after agreeing with participating in this study. (10)Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. (11)Males who donated over 400mL blood within the last three month to the current study. (12) Females who donated over 400mL blood within the last four month to the current study. (13) Males who will be collected over 1200mL blood, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (14) Females who will be collected over 800mL blood, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. (15)Others who have been determined ineligible by principal investigator or sub-investigator.

Design outcomes

Primary

MeasureTime frame
Number of defecation (days of defecation)

Secondary

MeasureTime frame
*Feces property (amount, shape, color, smell, sensation after defecation) *Intestinal microflora *Physicochemical analysis of feces ( fecal organic acid, fecal decay products)

Countries

Japan

Contacts

Public ContactMasanori Numa

CPCC Company Limited Sales & Planning Department

cpcc-contact@cpcc.co.jp03-5297-3112

Outcome results

None listed

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