Clinical Trial: A study to evaluate the effect of bread and potato salad containing reduced digestible dextrin on blood glucose level and postprandial sleepiness -Randomized, open-label, cross-over single intake study- (Japan)

Tokyo, Sept. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062693) titled 'A study to evaluate the effect of bread and potato salad containing reduced digestible dextrin on blood glucose level and postprandial sleepiness' on Sept. 3.

Study Type: Interventional

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

Primary Sponsor: Institute - other

Condition: Condition - Healthy adult Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effects of bread alone versus bread plus potato salad containing reduced digestible dextrin on blood glucose levels and postprandial sleepiness. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Test food A: Single intake of 73.7 g of white bread Test food B: Single intake of 56.7 g of white bread + 80 g of potato salad containing 6.8 g of reduced digestible dextrin

Eligibility: Age-lower limit - 20 years-old

Gender - Male Key inclusion criteria - (1) Healthy Japanese males between 20 and 59 years of age. (2) BMI of 25 or less. (3) Who voluntarily wish to participate in the clinical trial and provide written consent. (4) Subjects who have not been advised by a physician to undergo treatment for any illness based on health checkup results within the past year. (5) Subjects without glucose intolerance or difficulty sleeping in checkups within the past year. (6) Subjects who are able to maintain a consistent daily lifestyle during the study period. Key exclusion criteria - (1) Subjects with a history or current history of serious diseases (diabetes, heart disease, liver disease, renal disease, gastrointestinal disease, cancer, etc.) or mental illness. (2) Subjects who fall under the "D (Medical care required)" judgment category of the Japan Society of Human Dry Dock. (3) Subjects who are unable to maintain their daily lifestyle due to significant changes in diet and physical activity. (4) Subjects with possible food or drug allergies to the test foods. (5) Subjects who routinely consume specified health foods, foods with functional claims, or health foods (including supplements) 3 or more times a week and cannot discontinue them during the study period after obtaining consent. (6) Subjects who routinely use medications that may affect the study (antibiotics, gastrointestinal regulators, laxatives, medications for mental illness or sleep disorders, etc.) and cannot restrict their use during the study period. (7) Subjects with sleep disorders (e.g., insomnia, sleep apnea syndrome, circadian rhythm sleep disorder, hypersomnia, etc.). (8) Subjects currently receiving any drug treatment or outpatient treatment. (9) Subjects who are otherwise judged ineligible for participation in this study by the lead principal investigator. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 03 Day Date of IRB - 2026 Year 07 Month 01 Day Anticipated trial start date - 2026 Year 07 Month 03 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071097

Disclaimer: Curated by HT Syndication.