Tokyo, June 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062001) titled 'Effects of consumption of the test food on postprandial blood glucose level in healthy Japanese' on June 22.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - J-OIL MILLS, Inc.
Condition:
Condition - Healthy Japanese
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the effect of the test food consumption on the postprandial blood glucose in healthy Japanese.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Duration: 8 weeks
Test product: Food
Interventions/Control_2 - Duration: 8 weeks
Test product: Placebo food
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 Cmax of the blood glucose level after consumption of the carbohydrate load is 140-199 mg/dL at screening (Scr)
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 are a smoker
5. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims
6. Individuals who are taking or using medications (including herbal medicines) or supplements
7. Individuals who cannot regularly take three meals (breakfast, lunch, and dinner) a day
8. Individuals who take dairy products such as milk and cheese at least four times a week
9. Individuals who are allergic to medications or foods related to the test food (particularly gelatin)
10. Individuals who are pregnant, lactating, or planning pregnancy during this study
11. Individuals who are deemed unsuitable for participation in this study by the principal investigator
Target Size - 106
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 22 Day
Last follow-up date - 2026 Year 12 Month 18 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070947
Disclaimer: Curated by HT Syndication.