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Effect of the test food on breath hydrogen excretion -A randomized, open-label, cross over study-

Effect of the test food on breath hydrogen excretion -A randomized, open-label, cross over study- - Effect of the test food on breath hydrogen excretion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035881
Enrollment
20
Registered
2019-02-15
Start date
2019-02-17
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

Single intake of test food- single intake of control food Single intake of control food- single intake of test food

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Male and Female aged from 20 to 65 years old at the time of informed consent is taken 2)Subjects whose BMI below 25 at the screening test 3)Subjects who eat 3 times a day 4)Subjects who agree to participate in the study on one's own will

Exclusion criteria

Exclusion criteria: 1)Subjects who are suffering from disease affect gastric emptying and digestion function 2)Subjects who have a surgical history of the digestive organs 3)Subjects who have a disease such as upper respiratory inflammation and acute gastroenteritis 4)Subjects who defecate 3 times or above per day 5)Subjects who defecate less than 3 times per week 6)Subjects who are suffering from indigestion symptoms 7)Subjects who have a habit of excessive alcohol 8)Subjects who smoke daily 9)Subjects who had taken antibiotics and/or anti-microbe a gents within 1 month prior to date of the informed consent, or who is going to taking them during study 10)Subjects who taking medicine that may affect the examination and subjects who eat daily brown rice, cereals etc 11)Subjects who take health food (a probiotic dairy product etc) excessively that may affect the examination 12)Subjects who is allergic to rice 13)Subjects who are pregnant or breast-feeding, or subjects who expect to be pregnant during this study 14)Subjects who participating in other clinical studies, or who are planning to participate in other clinical studies during the present study 15)Subjects whose fasting breath methane concentration is 10 ppm or above at the screening test 16)Subjects who are judged as unsuitable for the study by the investigator for other reasons

Design outcomes

Primary

MeasureTime frame
Breath hydrogen excretion(AUC 0-8h)

Secondary

MeasureTime frame
Breath hydrogen excretion(The observed values and the change from pre-intake of breath hydrogen excretion at each evaluation point)

Countries

Japan

Contacts

Public ContactEiji Yoshikawa

KSO Corporation Sales department

yoshikawa@kso.co.jp03-3452-7733

Outcome results

None listed

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