Tokyo, Aug. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062467) titled 'A verification study of the effects of test food consumption on postprandial blood glucose levels in healthy Japanese' on Aug. 4.

Study Type: Interventional

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

Primary Sponsor: Institute - Tsuno Rice Fine Chemicals Co., Ltd

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

Objective: Narrative objectives1 - To verify the effects of test food consumption on postprandial blood glucose levels in healthy Japanese Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Single ingestion

Test 1: Food containing rice bran extract Test 2: Food not containing rice bran extract Load food: Bread (Pasco Shikishima Corporation), strawberry jam (Sudo Jam Co., Ltd.)

Test 1: Consume 10 capsules with water 30 minutes before the load food consumption. Test 2: Consume 10 capsules with water 30 minutes before the load food consumption. Load food: At screening, after the completion of the pre-consumption test, and at the main test, 30 minutes after the test product consumption, consume 1 slice of bread (4-sliced) and 20 g of strawberry jam over 5 minutes.

*The daily dose should be consumed within the same day and should not be carried over to the following day. * Test 1 followed by Test 2. * The washout period is 1 week or more. Interventions/Control_2 - Single ingestion

Test 1: Food not containing rice bran extract Test 2: Food containing rice bran extract Load food: Bread (Pasco Shikishima Corporation), strawberry jam (Sudo Jam Co., Ltd.)

Test 1: Consume 10 capsules with water 30 minutes before the load food consumption. Test 2: Consume 10 capsules with water 30 minutes before the load food consumption. Load food: At screening, after the completion of the pre-consumption test, and at the main test, 30 minutes after the test product consumption, consume 1 slice of bread (4-sliced) and 20 g of strawberry jam over 5 minutes.

*The daily dose should be consumed within the same day and should not be carried over to the following day. * Test 1 followed by Test 2. * The washout period is 1 week or more.

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 blood glucose level is relatively high

6. Individuals whose IAUC of GLU is relatively large at screening

7. Individuals whose BMI is relatively high 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 medications (including herbal medicines) or supplements

6. Individuals who are allergic to medications or foods related to the test product (particularly, rice, wheat, milk ingredients, or pork)

7. Individuals who are smokers or have not yet completed one year since quitting smoking

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

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 07 Month 21 Day Date of IRB - 2026 Year 07 Month 21 Day Anticipated trial start date - 2026 Year 08 Month 04 Day Last follow-up date - 2026 Year 09 Month 25 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071497

Disclaimer: Curated by HT Syndication.