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A study to confirm the effect of mixed coffee with coffee oligosaccharide on defecation.-A randomized, double-blind,placebo-controlled, crossover comparative study -

A study to confirm the effect of mixed coffee with coffee oligosaccharide on defecation.-A randomized, double-blind,placebo-controlled, crossover comparative study - - A study to confirm the effect of mixed coffee with coffee oligosaccharide on defecation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049614
Enrollment
30
Registered
2023-02-01
Start date
2023-01-11
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 listed

Interventions

Sponsors

AJINOMOTO AGF, INC.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Japanese males and females aged of 20-64 years. 2)Subjects who defecate 2~5 times from the screening test per week. 3)Subjects who can visit on schedule days. 4)Subjects who recognize the object and contents of the study and submit the written informed consent.

Exclusion criteria

Exclusion criteria: 1)Subjects taking medicine laxatives or antibiotics. 2)Subjects unable to collect stool samples on the designated date. 3)Subjects taking pharmaceuticals (abortive medication is allowed). 4)Subjects with a history of serious liver, kidney, cardiovascular, gastrointestinal, pulmonary, blood, or metabolic disease. 5)Subjects who regularly use health foods and supplements affecting the study. 6)Subjects who have allergy related to the test foods 7)Subjects who are shift workers or graveyard shift workers. 8)Subjects with extremely irregular daily habits and eating habits. 9)Subjects who usually intake heavy amount of alcohol (40g alcohol/day>=) and who are excessive smoker(21 cigarettes/day>=). 10)Subjects who have systolic blood pressure <90 mmHg. 11)Subjects who feel bad mood by blood collection. 12)Subjects who donated 200 mL or more of blood within 1 month from the screening test. 13)Subjects already participating in other clinical trials. 14)Possible pregnancy, pregnancy and lactation. 15)Subjects who are ineligible due to physician's judgment.

Design outcomes

Primary

MeasureTime frame
Defecation survey

Secondary

MeasureTime frame
Intestinal flora

Countries

Japan

Contacts

Public ContactToyotada Ashino

New drug research center, Inc. Clinical Research Dept.

t-ashino@ndrcenter.co.jp0123-34-0412

Outcome results

None listed

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