Tokyo, Feb. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060631) titled 'Single Ingestion Study of Galactooligosaccharides' on Feb. 10.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Yakult Honsha Co., Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To compare post-ingestion changes in blood glucose levels after single administration of glucose, OLIGOMATE 55N, and high-purity galactooligosaccharides in healthy adults.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Single administration of the control food, followed by a 1-week washout, then single administration of Test Food 1, followed by another 1-week washout, and finally single administration of Test Food 2.
Interventions/Control_2 - Single administration of Test Food 1, followed by a 1-week washout, then single administration of Test Food 2, followed by a 1-week washout, and finally single administration of the control food.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Healthy adults
Key exclusion criteria - (1) Individuals who are pregnant or may become pregnant
(2) Individuals who are participating in or planning to participate in another clinical or volunteer study during the study period
(3) Individuals with diabetes mellitus
(4) Individuals taking medications that may affect blood glucose levels
(5) Individuals who report having allergies to the test foods
Target Size - 15
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 17 Day
Date of IRB - 2025 Year 12 Month 17 Day
Anticipated trial start date - 2026 Year 02 Month 10 Day
Last follow-up date - 2026 Year 03 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069348
Disclaimer: Curated by HT Syndication.
