Tokyo, Sept. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062791) titled 'An Exploratory Study of Gut Microbiota Associated with Lipid Metabolism in Healthy Adults' on Sept. 2.

Study Type: Observational

Primary Sponsor: Institute - The Nisshin OilliO Group, Ltd.

Condition: Condition - NA Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Fecal samples collected from healthy adults will be cultured in media supplemented with lipid components to explore and isolate gut bacteria potentially associated with lipid components. In addition fecal microbiome analysis will be performed to obtain baseline data on the gut microbial environment of the participants. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Japanese men and women aged 18 years or older and under 65 years at the time of written informed consent 2. Individuals who fully understand the objectives and details of the study and voluntarily provide written informed consent to participate Key exclusion criteria - 1. Diagnosis of constipation or a disease considered likely to significantly affect bowel movements 2. Current medication or outpatient treatment for any serious disease 3. Current exercise or dietary therapy under medical supervision 4. Current or past history of drug or alcohol dependence 5. Current outpatient treatment for a psychiatric or sleep disorder or a history of psychiatric disease 6. Irregular daily routines due to night work or shift work 7. Extremely irregular eating sleeping or other lifestyle habits 8. Extremely unbalanced dietary habits 9. Average pure alcohol intake of approximately 60 g or more per day or smoking 21 or more cigarettes per day 10. Current or past history of a serious brain malignant immune diabetic liver kidney cardiac thyroid adrenal or other metabolic disease 11. Current or planned use of antibiotics or other medications that may affect the gut microbiota 12. Overseas travel long term business travel or another event causing a substantial change in dietary habits within one month before informed consent 13. Participation in another clinical trial or study within three months before informed consent or planned participation during the study period 14. Current pregnancy or breastfeeding or the possibility of pregnancy during the study period 15. Difficulty complying with questionnaire recording requirements 16. Considered unsuitable based on clinical laboratory test results or questionnaire responses at screening 17. Otherwise considered unsuitable by the investigator responsible for the study site Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 09 Day Date of IRB - 2026 Year 07 Month 17 Day Anticipated trial start date - 2026 Year 09 Month 07 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071877

Disclaimer: Curated by HT Syndication.