Tokyo, June 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061861) titled 'A measurement study of blood beta- hydroxybutyric acid upon consumption of the test food: a randomized, placebo-controlled, double-blind, crossover study' on June 10.

Study Type: Interventional

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

Primary Sponsor: Institute - UHA Mikakuto Co.,Ltd.

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

Objective: Narrative objectives1 - To verify the effects of consumption of the test food on blood levels of beta-hydroxybutyric acid, insulin, and glucose. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Single ingestion

Test1: Low carb bar containing medium chain fatty acid Test2: Isocaloric low carb bar

*Test 1 followed by Test 2. *The washout period is one week. Interventions/Control_2 - Single ingestion

Test1: Isocaloric low carb bar Test2: Low carb bar containing medium chain fatty acid

*Test 1 followed by Test 2. *The washout period is one week.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals whose BMI is 18.0 or more and less than 25.0 Key exclusion criteria - 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction

2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims

5. Individuals who are taking or using medicines (including herbal medicines) or supplements

6. Individuals who are allergic to medicines and foods related to the test product, particularly those who are allergic to wheat, milk, soybeans, almonds, walnuts, oranges, bananas, apples, or cashew nuts.

7. Individuals who are pregnant, lactating, or planning pregnancy during this study

8. Individuals who are on ketogenic diet

9. Individuals who are deemed unsuitable for participation in this study by the principal investigator Target Size - 10

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 05 Month 27 Day Date of IRB - 2026 Year 05 Month 27 Day Anticipated trial start date - 2026 Year 06 Month 10 Day Last follow-up date - 2026 Year 08 Month 21 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070782

Disclaimer: Curated by HT Syndication.