Tokyo, Oct. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063147) titled 'Analysis of Biological Age and Gut Environment in Long-term Consumers of Food X' on Oct. 20.
Study Type:
Observational
Primary Sponsor:
Institute - SOUKEN Co., Ltd.
Condition:
Condition - Healthy Adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the association between long-term consumption of Food X and biological age and gut environment.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Japanese males and females aged 40 to 69 years at the time of informed consent.
(2) Healthy adults.
(3) Individuals who have received a full explanation of the study objectives and procedures, have understood the study, voluntarily agreed to participate, and are able to provide written informed consent.
(4) Individuals who have continuously consumed Food X for at least 6 months.
(5) Individuals who agree to continue consuming Food X until the study assessment day.
Key exclusion criteria - (1) Individuals who are pregnant, breastfeeding, or planning to become pregnant during the study period.
(2) Individuals diagnosed with or receiving treatment for specific diseases, including cancer, hematological disorders, or immune disorders.
(3) Individuals currently using specific medications, including anticancer drugs or immunosuppressive agents.
(4) Individuals with a history of gastrointestinal resection surgery (excluding appendectomy).
(5) Individuals who participated in another interventional study within 6 months prior to informed consent or who plan to participate in another interventional study during the study period.
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 24 Day
Date of IRB - 2026 Year 09 Month 24 Day
Anticipated trial start date - 2026 Year 10 Month 22 Day
Last follow-up date - 2026 Year 11 Month 19 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072277
Disclaimer: Curated by HT Syndication.