Tokyo, Sept. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063052) titled 'The Effect of Pre-meal Consumption of Fermented Food on Postprandial Blood Glucose Levels: A Randomized, Open-Label, Crossover Comparative Trial' on Sept. 25.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - KSO Corporation
Condition:
Condition - none
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine whether pre-meal intake of a fermented food suppresses the postprandial blood glucose response in middle-aged men.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Taking the test food once before meals -> Washout (7 days) -> Taking the control food (placebo) once before meals
Interventions/Control_2 - Taking the control food (placebo) once before meals -> Washout (7 days) -> Taking the test food once before meals
Eligibility:
Age-lower limit - 40
years-old
Gender - Male
Key inclusion criteria - (1) Men aged 40 to under 60 years at the time of consent.
(2) Persons who have received a full explanation of the purpose, content and methods of the study, understand the content of the study, and have given written consent of their own free will.
Key exclusion criteria - (1) Fasting blood glucose level of 126 mg/dL or higher.
(2) HbA1c level of 6.5% or higher.
(3) BMI of 30 kg/m2 or higher.
(4) Use of any medication that may affect glucose metabolism or appetite.
(5) Habitual consumption of Foods for Specified Health Uses, Foods with Function Claims, or other health foods or supplements that may affect glucose metabolism, which cannot be discontinued during the study period.
(6) Current or past history of hepatic, renal, cardiac, pulmonary, gastrointestinal, haematological, endocrine, metabolic, or other serious disease.
(7) Current history of an eating disorder or a taste disorder.
(8) Markedly irregular dietary or lifestyle habits considered inappropriate by the principal or sub-investigator.
(9) Absence of a regular habit of eating three meals per day.
(10) Difficulty in consuming the test food or the standardised meal.
(11) Food allergy to any ingredient of the test food or the standardised meal (milk, wheat, soybean, chicken, or pork).
(12) Skin disorder at the site of continuous glucose monitoring (CGM) sensor placement, or a predisposition to skin injury caused by adhesive tape.
(13) Scheduled clinical examination (radiography, computed tomography, or magnetic resonance imaging), airport baggage screening, treatment, or hospitalisation that may interfere with continuous CGM during the study period.
(14) Blood sampling or blood donation of 400 mL or more within 8 weeks before the date of consent.
(15) Current participation, or planned participation during the study period, in another clinical trial or study.
(16) Any other condition that, in the judgement of the principal or sub-investigator, renders the individual unsuitable for participation on the basis of background characteristics, physical findings, medical interview, physical examination, or laboratory test results.
Target Size - 26
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 02 Day
Date of IRB - 2026 Year 09 Month 17 Day
Anticipated trial start date - 2026 Year 09 Month 26 Day
Last follow-up date - 2027 Year 02 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072182
Disclaimer: Curated by HT Syndication.
