Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060262) titled 'Verification of the Comprehensive Health Effects Originating from the Gut Environment of the Test Food' on April 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Kobe Women's University
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to examine the effects of consuming the test food on bowel movements, sleep, mental health, and other related parameters.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants will freely consume the test food, an unprocessed food that has been eaten in Japan since ancient times, twice a day at home for four weeks.
Interventions/Control_2 - Participants will freely consume the placebo test food - an unprocessed food - twice daily at home for a period of four weeks.
Eligibility:
Age-lower limit - 18
years-old
Gender - Female
Key inclusion criteria - Participants will be healthy adult women who understand the study's purpose and content and submit written informed consent before the start of the trial.
Key exclusion criteria - Individuals with barley or wheat allergies, as well as those who regularly use supplements or medications that may affect bowel movements, sleep, or mental health, will be excluded.
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 01 Day
Anticipated trial start date - 2026 Year 05 Month 11 Day
Last follow-up date - 2026 Year 07 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068898
Disclaimer: Curated by HT Syndication.
