Tokyo, April 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061296) titled 'A Study on How Functional Cookies Made with Rice Bran and Okara Affect Postprandial Blood Glucose Levels' on April 17.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Placebo
Primary Sponsor:
Institute - Sugiyama Jogakuen University
Condition:
Condition - Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to develop cookies using rice bran and okara as raw materials, evaluate their palatability and their ability to suppress postprandial blood glucose elevation, and examine their potential as functional foods.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants consume butter cookies (Sample A), standardized to provide 50 g of carbohydrates, followed by continuous glucose monitoring for 3 hours.
Interventions/Control_2 - Participants consume rice bran cookies (Sample B), standardized to provide 50 g of carbohydrates, followed by continuous glucose monitoring for 3 hours.
Eligibility:
Age-lower limit - 21
years-old
=
Gender - Female
Key inclusion criteria - Healthy young adult women
Aged approximately 18 to 25 years
Individuals who receive a full explanation of the study and provide written informed consent
Individuals who are able to wear a continuous glucose monitoring device and ingest the test cookies and sucrose solution without difficulty
Key exclusion criteria - Individuals with a history of diabetes, impaired glucose tolerance, or endocrine disorders
Individuals taking medications that may affect glucose metabolism
Individuals with food allergies to wheat, milk, eggs, soy, rice bran, okara, or related ingredients
Pregnant women or those who may be pregnant
Individuals deemed inappropriate for participation by the principal investigator
Target Size - 11
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2025 Year 05 Month 25 Day
Date of IRB - 2025 Year 06 Month 30 Day
Anticipated trial start date - 2025 Year 07 Month 19 Day
Last follow-up date - 2025 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070137
Disclaimer: Curated by HT Syndication.
