Clinical Trial: Mechanisms Underlying Differences in Postprandial Glycemic Responses After Breakfast and Dinner Intake, with a Focus on Digestive and Absorptive Function (Japan)

Tokyo, Jan. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060402) titled 'Elucidation of the Mechanisms Underlying Differences in Glycemic Responses After Breakfast and Dinner Intake: A Perspective on Digestive and Absorptive Function' on Jan. 19.

Study Type: Interventional

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

Primary Sponsor: Institute - Prefectural University of Hiroshima

Condition: Condition - Adult Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To elucidate the mechanisms responsible for differences in postprandial glycemic responses between breakfast and dinner, focusing on digestive and absorptive functions. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Ten healthy adults will consume a 400-kcal liquid meal (two bottles of Meibalance Mini) in the morning (09:00). Superior mesenteric artery blood flow will be assessed using Doppler ultrasonography, and gastric emptying will be evaluated by ultrasonography, from before meal ingestion to 180 minutes postprandially. Blood glucose, insulin, and free fatty acid levels will be measured at regular intervals before and after the meal. Diet-induced thermogenesis will be assessed by indirect calorimetry. Interventions/Control_2 - Ten healthy adults will consume a 400-kcal liquid meal (two bottles of Meibalance Mini) in the evening (18:30). Superior mesenteric artery blood flow will be assessed using Doppler ultrasonography, and gastric emptying will be evaluated by ultrasonography, from before meal ingestion to 180 minutes postprandially. Blood glucose, insulin, and free fatty acid levels will be measured at regular intervals before and after the meal. Diet-induced thermogenesis will be assessed by indirect calorimetry.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1.Aged 18 to 59 years 2.Not taking any medications or dietary supplements 3.Free from any medical or surgical diseases 4.Non-smokers 5.Not participating in any other research studies during the study period (confirmed by direct verbal inquiry at the time of study explanation) 6.Able to consume the meals provided in the study 7.Having a regular menstrual cycle Key exclusion criteria - 1.Aged under 18 years or 60 years and older 2.Taking any medications or dietary supplements 3.Having any medical or surgical diseases 4.Current smokers 5.Planning to participate in, or currently participating in, other research studies during the study period 6.Unable to consume the meals provided in the study due to food allergies 7.Pregnant, planning to become pregnant during the study period, or within one year postpartum Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 04 Month 04 Day Date of IRB - 2025 Year 04 Month 04 Day Anticipated trial start date - 2026 Year 01 Month 31 Day Last follow-up date - 2026 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069100

Disclaimer: Curated by HT Syndication.