Clinical Trial: A Preliminary Study on the Effects of Dietary Management Using Digital Technology on Body Weight and Continuous Glucose Monitoring Parameters (Japan)

Tokyo, March 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061046) titled 'A Preliminary Study on the Effects of Dietary Management Using Digital Technology on Body Weight and Continuous Glucose Monitoring Parameters' on March 25.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Kanazawa University

Condition: Condition - None Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective of this study is to evaluate changes in body weight and continuous glucose monitoring parameters associated with the use of digital dietary management tools voluntarily selected by the participants. Specifically, changes between Week 1 and Week 2 will be assessed in terms of absolute body weight change (kg) and relative body weight change (%), as well as changes in continuous glucose monitoring metrics, including mean glucose, coefficient of variation (CV), Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), and Glucose Management Indicator (GMI). Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - During Week 1, participants will undergo an observation period without the use of digital dietary management tools. During Week 2, they will engage in a dietary management period using a generative AI tool, a diet and health management application, or both, according to their own choice. Throughout the study period, continuous glucose monitoring using the FreeStyle Libre 2, daily body weight measurement, and meal photo recording will be conducted. Prompts entered into the generative AI tool will not be standardized.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1) Adults aged 20 to 75 years 2) Able to perform basic smartphone or PC operations 3) Able to understand the study and provide written informed consent 4) Able to complete the 2-week observation period 5) Not meeting any exclusion criteria Key exclusion criteria - 1) Women who are pregnant or breastfeeding 2) Patients with diabetes receiving insulin therapy 3) Individuals who have undergone surgery requiring general anesthesia within the past 3 months 4) Individuals currently under treatment for severe psychiatric disorders 5) Individuals judged to have insufficient cognitive ability to understand the study and provide appropriate informed consent 6) Individuals for whom placement of the FreeStyle Libre 2 sensor is difficult (e.g., severe skin disease, wounds or infection at the application site, history of adhesive allergy, or physical difficulty in sensor placement) 7) Individuals currently receiving treatment for eating disorders 8) Individuals on dialysis or with urinary protein of 1+ or greater 9) Individuals with severe hepatic dysfunction (Child-Pugh class C) 10) Individuals who have participated in another clinical study or trial within the past 1 month 11) Individuals judged by the principal investigator to be inappropriate for participation Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 06 Day Date of IRB - 2026 Year 02 Month 18 Day Anticipated trial start date - 2026 Year 03 Month 25 Day Last follow-up date - 2027 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069855

Disclaimer: Curated by HT Syndication.