Tokyo, Jan. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060309) titled 'A Randomized Open-Label Crossover Trial on the Effects of Pre-Meal Intake of Fermented Foods on Dietary Intake' on Jan. 11.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - KSO corporation
Condition:
Condition - None
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To confirm the effects of pre-meal intake of fermented foods on dietary content, satiety, and food preferences in healthy women.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Taking fermented food once before meals
Interventions/Control_2 - Not taking fermented food before meals
Eligibility:
Age-lower limit - 20
years-old
Gender - Female
Key inclusion criteria - (1)Women aged between 20 and 34 years old at the time of consent acquisition.
(2)BMI ranging from 18.5 kg/m2 to < 25 kg/m2.
(3)Persons who have been sufficiently informed of the purpose and content of the study, have the capacity to consent, and have voluntarily volunteered to participate in the study based on a thorough understanding of the purpose and content of the study, and have given their consent to participate in the study in writing.
Key exclusion criteria - (1)Persons with a current or past medical history of severe liver dysfunction, kidney disease, cardiovascular disorders, respiratory disorders, endocrine disorders, metabolic disorders, digestive disorders, eating disorders, or taste disorders.
(2)Persons with digestive disorders affecting digestion and absorption, or a history of digestive tract surgery (excluding appendicitis).
(3)Persons regularly taking prescription drugs or quasi-drugs.
(4)Persons unable to discontinue consumption of health foods (including foods for specified health uses and foods with functional claims) or supplements during the trial period.
(5)Persons not consuming three regular meals per day.
(6)Persons with food allergies.
(7)Persons who habitually engage in severe selective eating or dietary restrictions.
(8)Persons who have difficulty consuming test foods and prescribed meals.
(9)Pregnant persons, persons planning to become pregnant during the trial period, and persons who are breastfeeding.
(10)Persons with irregular menstrual cycles.
(11)Persons with irregular work schedules, such as shift work or night work.
(12)Persons with a current or past history of drug dependence or alcohol dependence.
(13)Persons with a history of smoking.
(14)Persons who have participated in trials involving other drugs or foods within the past month, or who intend to participate in such trials.
(15)Persons deemed unsuitable as subjects by the principal investigator or sub-investigator.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 27 Day
Anticipated trial start date - 2026 Year 01 Month 19 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068988
Disclaimer: Curated by HT Syndication.
