Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062314) titled 'Multifaceted evaluation of the effects of Yokan consumption on postprandial blood glucose fluctuations' on July 24.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Toraya confectionery Co.,Ltd.
Condition:
Condition - healthy person
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - testing the effects of Japanese sweets ingredients on reducing glycative stress
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - cooked rice
Interventions/Control_2 - Smooth red bean paste
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1) Men and women aged 18 to 59 at the time of obtaining consent for study participation
2) Healthy individuals with no chronic physical illnesses
3) Individuals who have received a full explanation of the study's purpose and content, possess the capacity to consent, fully understand the information, voluntarily wish to participate, and are able to provide written consent for participation
4) Individuals able to visit the designated location and undergo examinations on the scheduled dates
5) Individuals deemed suitable for participation in the study by the principal investigator
Key exclusion criteria - 1)Individuals currently suffering from a medical condition and undergoing pharmacological treatment
2)Individuals with a history or current diagnosis of impaired glucose tolerance,psychiatric disorders,sleep disorders,hypertension,diabetes,hyperlipidemia,or other serious medical conditions
3)Individuals who have regularly taken medication for the treatment of a medical condition within the past month.
4)Individuals with a history or current diagnosis of serious disorders affecting the liver,kidneys,heart,lungs,blood,etc
5)Individuals with a history or current diagnosis of gastrointestinal disorders
6)Individuals with a BMI of 30 kg/m2 or higher
7)Individuals who have donated more than 200mL of blood within the past month or more than 400mL within the past three months
8)Individuals with severe anemia
9)Individuals at risk of allergic reactions to the test food,or at risk of severe allergic reactions to other foods or pharmaceuticals
10)Individuals who are pregnant,breastfeeding,or potentially pregnant
11)Individuals who currently-or within the past three months-regularly consume Foods with Function Claims or health foods marketed for effects on glucose metabolism.
12)Individuals otherwise deemed unsuitable for the study by the principal investigator
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 09 Day
Date of IRB - 2026 Year 03 Month 10 Day
Anticipated trial start date - 2026 Year 07 Month 25 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071307
Disclaimer: Curated by HT Syndication.