Tokyo, July 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062229) titled 'Exploratory study on long-term yogurt ingestion and glycemic variability in local residents of Fukui Prefecture' on July 14.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - THE PHAGE, Inc.

Condition: Condition - Prediabetes (Individuals at high risk for type 2 diabetes) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to exploratorily evaluate the suppressive effect of long-term (12-week) ingestion of yogurt containing MI-2 lactic acid bacteria on postprandial glucose spikes in local residents with prediabetes who are at high risk for type 2 diabetes. Utilizing the FreeStyle Libre 2 system and a dietary management app (glucose flight), we will clarify the detailed changes in glycemic dynamics. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake of yogurt for 12 weeks Interventions/Control_2 - No treatment

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese men and women aged 18 years or older. 2. Individuals with an HbA1c level between 5.6% and 6.4% within one year prior to obtaining informed consent. 3. Residents of Fukui Prefecture or neighboring areas who can regularly visit the designated medical institution. 4. Individuals who own a smartphone and can appropriately install and operate the designated apps (glucose flight, LibreLink, etc.) and record/take photos of meals. Key exclusion criteria - 1. Individuals already diagnosed with diabetes and using diabetes medications (oral hypoglycemic agents, GLP-1 receptor agonists, insulin, etc.). 2. Individuals who regularly consume health foods, supplements, Foods for Specified Health Uses (FOSHU), or Foods with Function Claims that claim to lower or maintain blood glucose levels and who are unable to discontinue their use during the study period (from screening to the end of the study). 3. Women who are pregnant, lactating, or may be pregnant. 4. Patients with severe hepatic or renal disease. 5. Individuals with a milk allergy, a history of lactose intolerance, or otherwise considered unsuitable for yogurt consumption. 6. Individuals who plan to remove the FreeStyle Libre 2 sensor during the study period (e.g., for health checkups), or who are judged to have difficulty maintaining compliance during the study period. 7. Others judged inappropriate by the principal investigator. Target Size - 300

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 06 Month 25 Day Date of IRB - 2026 Year 07 Month 05 Day Anticipated trial start date - 2026 Year 07 Month 13 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071184

Disclaimer: Curated by HT Syndication.