Tokyo, Jan. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060341) titled 'Study on the effect of Japanese black tea on suppressing postprandial blood glucose and insulin levels (Randomized Crossover Trial)' on Jan. 13.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Wayo Women's University
Condition:
Condition - Adult Men and Women with High Postprandial Blood Glucose Levels
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study will examine the inhibitory effect of Japanese black tea extract on postprandial blood glucose and insulin levels in adult men and women with high postprandial blood glucose levels in a randomized crossover trial.
Basic objectives2 - Bio-availability
Intervention:
Interventions/Control_1 - Test food intake - washout - placebo food intake
Interventions/Control_2 - Placebo food intake - washout - Test food intake
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1.A healthy young women
2.Subjects whose postprandial blood glucose peaks were higher than the median for all subjects.
Key exclusion criteria - 1.Subjects with a history of diabetes
2.Subjects with fasting blood glucose levels of 126 mg/dL or higher
3.Subjects who regularly use medications, 'Food for Specified Health Uses', 'Foods with Functional Claims'that may affect blood glucose levels
4.Subjects who are pregnant or willing to be pregnant or breast-feeding during this study
Target Size - 10
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 12 Month 16 Day
Date of IRB - 2025 Year 12 Month 24 Day
Anticipated trial start date - 2026 Year 02 Month 01 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069032
Disclaimer: Curated by HT Syndication.