A clinical study for evaluating of the effect of a supplement containing plant extract on the gut microbiome. -A Randomized, Double-blind, Placebo controlled, parallel-group Study- - A clinical study for evaluating of the effect of a supplement containing plant extract on the gut microbiome.

FUKUOKA KINEN PET KENSHIN CENTER0 sites30 target enrollmentDecember 1, 2022

Overview

No summary available.

Registry

who.int

Start Date

December 1, 2022

End Date

April 30, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

FUKUOKA KINEN PET KENSHIN CENTER

•1\. Subjects with hepatic, renal, cardiac or organ disorders or diabetes or other serious diseases. 2\. Subjects with a surgical history of digestive system (except appendicectomy). 3\. Subjects currently under treatment with chronic diseases. 4\. Subjects with food allergies to the food ingredients used in the test. 5\. Subjects who cannot refrain from ingesting lactic acid bacteria and dietary fiber\-enriched foods that may affect on the intestinal functions from 1 week before ingestion of test food to the final stool collection day. 6\. Subjects who wish to become pregnant during the study period (including the possibility of pregnant) or who are lactation or pregnant. 7\. Heavy drinkers (average amount of intake as pure alcohol is 60 g or more per day). 8\. Subjects who are participating in clinical trials or monitors other than this study or who are planning to participate during this study period. 9\. Subjects who have donated or plan to donate 200 ml or more of blood separately from this study from 1 month before the primary screening to the end of the study. 10\. Subjects who frequently skip food. 11\. Subjects who work from 22:00 to 6:00 (shift worker, night\- shift worker, etc). 12\. Subject who cannot consume foods whose origin is not clearly indicated due to religious or other reasons. 13\. Subjects judged as unsuitable for this study by the investigator for other reasons.