Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058863) titled 'A study on colonic drug delivery' on Oct. 1.

Study Type: Observational

Primary Sponsor: Institute - Ajinomoto Co., Inc.

Condition: Condition - obesity and type 2 diabetes Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Indole-3-propionic acid, a tryptophan metabolite by gut bacteria, is known to have ameliorative effects on obesity and type 2 diabetes. Therefore, the aim of this study is to elucidate the optimal formulation design to deliver tryptophan to the colon. Basic objectives2 - PK,PD

Eligibility: Age-lower limit - 20 years-old = Gender - Male Key inclusion criteria - -Those who are able to eat three meals a day. -Those who have a bowel movement once a day, basically in the morning. -Those who are able to stay at the Aiwa Clinic from Friday night to Monday around noon. -Those who have been fully informed of the purpose and content of the research, have the capacity to consent, and have voluntarily volunteered to participate based on a thorough understanding of the purpose and content of the research, and have given their consent to participate in the research in writing. Key exclusion criteria - -Those who are judged to be unsuitable as research subjects in the clinical examination and vitals conducted for the screening test. -Those who have chronic diseases, regularly use drugs or medicines, or have serious complications. -Those who are taking health foods (including food for specified health use and functional foods) on a daily basis. -Those who have gastrointestinal diseases that affect digestion and absorption, and those who have a history of gastrointestinal surgery. -Those who will sweat profusely or exercise during the study period. -Those who have a tendency to constipation or diarrhea. -Those who cannot refrain from excessive protein intake (e.g., eating all-you-can-eat grilled meat, consuming protein drinks, etc.) during the period of this study. -Those who have a nocturnal rhythm in their daily life. -Those who have donated blood within 4 weeks prior to the start of the study and those who plan to donate blood during the study period and within 4 weeks of the end of the intake. -Those who are currently participating or intend to participate in research involving the ingestion of other foods, drugs, etc., or the application of cosmetics, drugs, etc. -Other persons who are judged by the principal investigator to be inappropriate as research subjects. Target Size - 9

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2023 Year 10 Month 31 Day Date of IRB - 2023 Year 12 Month 15 Day Anticipated trial start date - 2024 Year 01 Month 20 Day Last follow-up date - 2025 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061005

Disclaimer: Curated by HT Syndication.