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A study for evaluating the effects of the intake of cocoa on bowel movement and fecal malodor. A placebo-controlled crossover trial.

A study for evaluating the effects of the intake of cocoa on bowel movement and fecal malodor. A placebo-controlled crossover trial. - A study for evaluating the effects of the intake of cocoa on bowel movement and fecal malodor.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022433
Enrollment
20
Registered
2017-09-30
Start date
2016-05-25
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

Subjects with a tendency for constipation

Interventions

Intake of a drink containing cocoa for 2 weeks, wash out for 2 weeks, Intake of a drink without cocoa for 2 weeks Intake of a drink without cocoa for 2 weeks, wash out for 2 weeks, Intake of a drink c

Sponsors

QOL RD Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1)Males and females from 20 to 60 years old (2)Subjects with a tendency for constipation at two to five times defecation per week (3)Healthy subjects with not taking any medicine (4)Subjects who can keep their stools in freeze immediately after defecation (5)Obtaining informed consent and signed a consent form

Exclusion criteria

Exclusion criteria: 1) Subjects with a serious liver, kidney, heart damage, diabetes, food allergies, digestive disorder, suffering other serious diseases 2) Subjects having medical history or operation history of digestive disorder 3) Subjects cannot keep the lifestyle 4) Subjects cannot regularly have three meals a day 5)Shifts workers or Late-night workers 6) Subjects whose amount of dietary intake or exercise has changed significantly 7) Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study. 8) Subjects who take any kind of medicine and/or food for specified health uses and/or supplements and/or diet foods 9) Subjects with drug and food allergies 10) Subjects with a hypersensitivity reaction to test food (eczema, nausea, diarrhea, etc.) 11) Subjects cannot ingest the test food as directed 12) Subjects who usually drink more than 500ml of beer in terms of per day 13) Subjects who take dietary fiber, fermented foods, foods containing a lot of lactic acid bacteria or bifidobacteria or another living bacteria or oligosaccharide or chocolate or cocoa 14) Subjects who will smoke during the test period 15) Subjects cannot wright a life diary everyday 16) Subjects who cannot avoid food intake, which influences on fecal odor, on the day before sampling feces 17) Subjects who participate other clinical trials or investigates in this trial 18) Subjects who are judged not applicable to this study by representative investigator or investigator

Design outcomes

Primary

MeasureTime frame
Defecation frequency, fecal amount, fecal odor

Secondary

MeasureTime frame
Fecal conditions(fecal hardness, fecal color, fecal shape, feeling after defecation), fecal ammonia content, fecal putrefaction products content(indole, skatol)

Countries

Japan

Contacts

Public ContactHaruka Yoshimoto

QOL RD Co.,Ltd. CRO Department Food Division

h-yoshimoto@qol-rd.co.jp03-6386-8809

Outcome results

None listed

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