Tokyo, Oct. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063179) titled 'Evaluation of lipid absorption after intake of a test food' on Oct. 7.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Active

Primary Sponsor: Institute - Taiyo Yushi Corp.

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

Objective: Narrative objectives1 - The purpose of this study is to evaluate the effects of test food intake on blood lipid-related parameters and the safety of a single intake of the test food. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Single intake of pilaf containing 40 g of the test food with clear soup - one-week washout period - single intake of pilaf containing 40 g of the control food with clear soup. Interventions/Control_2 - Single intake of pilaf containing 40 g of the control food with clear soup - one-week washout period - single intake of pilaf containing 40 g of the test food with clear soup.

Eligibility: Age-lower limit - 20 years-old = Gender - Male Key inclusion criteria - 1. Healthy Japanese male subjects aged 20 to 39 years. 2. Subjects with a BMI of 18.5 kg/m2 or higher and less than 25.0 kg/m2. 3. Subjects who have received a sufficient explanation of the purpose and details of the study, have understood the study, and have voluntarily agreed to participate in the study by providing written informed consent. Key exclusion criteria - 1. Subjects with a current or past history of lipid or glucose metabolism disorders, thyroid, liver, biliary, kidney or pancreatic disease, malabsorption, or other diseases affecting lipid metabolism. 2. Subjects unable to stop using drugs, quasi-drugs, health foods, foods for specified health uses, foods with function claims, supplements, or probiotic drinks that may affect lipid/glucose metabolism, digestion, absorption, or gastrointestinal function. 3. Subjects with excessive alcohol intake: average daily alcohol intake >=20 g, or intake >=60 g on one occasion at least four times during the past 4 weeks. 4. Smokers or regular users of heated tobacco, e-cigarettes, or other nicotine products. 5. Subjects who regularly perform strenuous exercise, including competitive sports or gym exercise several times a week. 6. Subjects unable to fast for at least 12 h before a study visit. 7. Subjects unable to avoid alcohol and strenuous exercise for 48 h before a study visit. 8. Subjects unable to avoid caffeinated beverages, energy drinks, chewing gum, and supplements on a study visit day. 9. Subjects with food allergy, intolerance, or hypersensitivity. 10. Subjects planning to change their lifestyle or diet during the study. 11. Subjects on a carbohydrate-restricted or weight-loss diet. 12. Subjects who donated or had >200 mL of blood collected within 1 month, or >400 mL within 3 months before screening. 13. Subjects judged unsuitable for the study by the principal investigator or subinvestigator. Target Size - 14

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 15 Day Date of IRB - 2026 Year 10 Month 01 Day Anticipated trial start date - 2026 Year 10 Month 07 Day Last follow-up date - 2026 Year 11 Month 06 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072218

Disclaimer: Curated by HT Syndication.