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Clinical Trials/JPRN-UMIN000045361
JPRN-UMIN000045361
Completed
未知

A study for evaluating the safety of the intake of a test food. - A study for evaluating the safety of the intake of a test food.

EP Mediate Co., Ltd.0 sites48 target enrollmentDecember 21, 2022
ConditionsHealthy adult

Overview

Phase
未知
Intervention
Not specified
Conditions
Healthy adult
Sponsor
EP Mediate Co., Ltd.
Enrollment
48
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 21, 2022
End Date
December 21, 2021
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • (1\) Those who regularly use foods (including foods for specified health uses) that contain a lot of dietary fiber materials (indigestible dextrin, polydextrose, indigestible glucan, etc.) (2\) Those who regularly use medicines, health foods, foods for specified health uses, or functional foods that may affect bowel movements. (3\) Those who are in the habit of consuming a large amount of foods that are thought to affect bowel movements (foods rich in dietary fiber and lactic acid bacteria) (4\) Persons who are visiting a hospital and using medication for a bowel movement\-related disease or who are regularly using over\-the\-counter laxatives at the time of research participation. (5\) Those with a history or current condition of drug or alcohol dependence. (6\) Persons with serious diseases such as diabetes, liver disease, renal disease, cardiac disease, or those with pre\-existing diseases. (7\) Persons at risk of developing allergies related to the research. (8\) Those with a disease under treatment or with a history of serious disease that required medication. (9\) Persons whose anthropometric, physical, and clinical values are significantly out of the reference range before the start of intake. (10\) Those who have participated in other clinical research within one month prior to obtaining consent to participate in this study, or those who plan to participate in other clinical research after obtaining consent to participate in this. (11\) Those who are pregnant or plan to become pregnant or breastfeed during the study period. (12\) Those who are judged to be unsuitable as subjects based on the answers to the lifestyle questionnaire. (13\) Any other person who is judged as inappropriate as a subject by the Chief Medical Officer.

Outcomes

Primary Outcomes

Not specified

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