Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062528) titled 'Study on bioavailability of sugarcane bagasse-containing ice cream in humans' on Aug. 9.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Nakamura Gakuen University

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

Objective: Narrative objectives1 - To evaluate the effects of a single ingestion of a cold confection (ice cream) containing sugarcane bagasse on postprandial blood glucose and insulin levels, and to assess its fermentability and utilization by gut microbiota in the large intestine (via breath hydrogen output), thereby clarifying its bioavailability and safety in humans. Basic objectives2 - Bio-availability

Intervention: Interventions/Control_1 - Duration: 1 day (Single ingestion, with a washout period of at least 1 week between tests) Test material: Plain black tea-flavored ice cream (Control) Dose: Approx. 150 g Administration: Ingest once in the early morning under fasting conditions. Interventions/Control_2 - Duration: 1 day (Single ingestion, with a washout period of at least 1 week between tests) Test material: 1.5% Sugarcane bagasse-containing black tea-flavored ice cream Dose: Approx. 150 g Administration: Ingest once in the early morning under fasting conditions.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - Healthy Japanese adult men and women Key exclusion criteria - The exclusion criteria are diabetes mellitus, abnormal glucose metabolism, respiratory disease, chronic gastrointestinal disease (inflammatory bowel disease, irritable bowel syndrome, functional dyspepsia, etc.), abdominal surgery, history of abnormal bowel movements, blood disorders, food allergies, or a BMI of 25.0 or higher. Smokers, individuals with excessive alcohol intake, and pregnant or lactating women will be excluded. Also excluded are those who regularly consume non-digestible and absorbable saccharides (such as dietary fiber), and those who routinely consume pharmaceuticals (such as antibiotics), foods for specified health uses, functional foods, or health foods. Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 29 Day Date of IRB - 2026 Year 08 Month 06 Day Anticipated trial start date - 2026 Year 08 Month 17 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=R000071565

Disclaimer: Curated by HT Syndication.