Tokyo, April 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061242) titled 'Observational study on the intestinal environment among Dstyle users' on April 13.
Study Type:
Observational
Primary Sponsor:
Institute - BIOSIS Lab. Co., Ltd.
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the association between gut microbiota and lifestyle in Japanese men and women aged 18 and older who are users of Dstyle.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate.
2.Japanese men and women who are Dstyle users and are 18 years of age or older at the time of consent.
Key exclusion criteria - 1.Persons who have chronic illness, receiving medication, or have a serious disease history.
2.Persons who usually take medicine or Food with Health Claims (Food for Specified Health Uses, Foods with Functional Claims, and Foods with Nutrient Function Claims) that may affect the intestinal environment.
3.Persons who have participated in other studies within one month before the start of the study, or those who intend to participate in another study after consenting to this study.
4.Persons who are pregnant, planning or hoping to be pregnant during the study period, or breastfeeding.
5.Persons who were judged as inappropriate for study participants by the principal investigator.
Target Size - 500
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 04 Month 04 Day
Anticipated trial start date - 2026 Year 04 Month 04 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070057
Disclaimer: Curated by HT Syndication.