Effects of OMF-01 on bowel movement of healthy volunteers with a tendency for constipation

Effects of OMF-01 on bowel movement of healthy volunteers with a tendency for constipation - Effects of OMF-01 on bowel movement of healthy volunteers with a tendency for constipation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022262

Enrollment

Registered

2016-05-11

Start date

2016-05-11

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

Healthy adult

Interventions

Intake OMF-01 for 2 weeks , washout for 2 weeks , Intake Dextrin powder for 2 weeks Intake Dextrin powder for 2 weeks , washout for 2 weeks , Intake OMF-01 for 2 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Subjects with male: age 40 to 70, female: after menopause 2)Subjects with a tendency for constipation(2-4 times / week) 3)Healthy Subjects with no-treatment 4)Obtaining informed consent and signed a consent form

Exclusion criteria

Exclusion criteria: 1) Subjects with a serious liver, kidney, heart damege, 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 oligosacccharide 14) Subjects who smoked more than 20 average daily 15) Subjects cannot wright a life diary everyday 16) Subjects who participate other clinical trials or investigates in this trial 17) Subjects who are judged not applicable to this study by representative investigator or investigator

Design outcomes

Primary

Measure	Time frame
bowel movements (frequency, volume, condition) in the ingestion period	—

Secondary

Measure	Time frame
flora, organic acid, putrefactive products, IgA in feces	—

Countries

Japan

Contacts

Public ContactNatsumi Oka

QOL RD Co.,Ltd. CRO Department Food Division

n-oka@qol-rd.co.jp03-6386-8809

Outcome results

None listed

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