Tokyo, Aug. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058720) titled 'A cross-sectional study of gut microbiota' on Aug. 7.
Study Type:
Observational
Primary Sponsor:
Institute - Otsuka Pharmaceutical Co., Ltd.
Condition:
Condition - Healthy Volunteer
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To explore the relationship between gut microbiota and muscle parameters in healthy volunteers.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 50
years-old
Gender - Male and Female
Key inclusion criteria - 1) Subjects who are voluntarily giving written informed consent.
2) Healthy volunteers aged between 50 and 79.
3) Subjects whose BMI is below 30.
Key exclusion criteria - (1) Subjects who cause allergic symptoms in foods and medicines.
(2) Subjects who contract or are under treatment for diseases.
(3) Subjects with systolic blood pressure of 140 mmHg or more or diastolic blood pressure of 90 mmHg or more at screening test.
(4) Alcoholic drinkers (more than 40 grams of pure alcohol per day).
(5) Subjects whose dietary patterns are highly irregular and may interfere with the study outcomes.
(6) Subjects who can't stop using, medicin, supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) during test periods.
(7) Subjects with exercise habits that may influence the outcomes of the study.
(8) Subjects who are judged unsuitable for the current study by the investigator for other reasons.
Target Size - 250
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 31 Day
Anticipated trial start date - 2025 Year 08 Month 27 Day
Last follow-up date - 2025 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067145
Disclaimer: Curated by HT Syndication.
