Tokyo, Feb. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059764) titled 'The effect of honey intake on blood glucose responses' on Feb. 20.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Yamada Bee Company, Inc.
Condition:
Condition - Adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the change of blood glucose level by the test foods
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake of a test food 1- washout period - a test food 2
Dose: 250ml
Single ingestion
Interventions/Control_2 - Intake of a test food 2- washout period - a test food 1
Dose: 250ml
Single ingestion
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Healthy males and females, aged 20 to 59 years at the time of providing consent
(2) Subjects with a BMI of less than 30 kg/m2
(3) Subjects who are able to provide fingertip blood sample (8 times/day for 3 observation periods)
(4) Subjects with normal blood glucose and HbA1c levels based on examinations in the past year, and who have not been advised to visit a hospital
(5) Subjects who have provided voluntary, written informed consent after fully understanding the details of the study
Key exclusion criteria - (1) Subjects who may develop allergies to the test food
(2) Subjects with a history of major surgery in the gastrointestinal tract, such as gastrectomy, gastrointestinal suture, or bowel resection
(3) Subjects who have chronic illness or disability in the liver, biliary tract, gastrointestinal tract, circulatory system, kidney, urinary system, psychiatric, nervous and hematological system
(4) Subjects who use health foods that contain ingredients that may affect the blood glucose level (unless they can discontinue use at least 1 week prior to the screening examination)
(5) Subjects who are routinely taking medicines known to affect blood glucose levels
(6) Subjects who are currently taking steroids, protease inhibitors or antipsychotics
(7) Subjects who are participating in another clinical trial at the time of screening
(8) Subjects who are pregnant, breast-feeding, or planning to become pregnant or breast-feeding during the study period
(9) Subjects who are unable to comply with the study requirements
(10) Subjects who are judged as ineligible for the subject of this study by investigator
Target Size - 28
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 21 Day
Anticipated trial start date - 2025 Year 11 Month 18 Day
Last follow-up date - 2026 Year 02 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068231
Disclaimer: Curated by HT Syndication.
