Tokyo, Oct. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059593) titled 'Investigation to confirm the effect of consuming the test food on improving sleep quality' on Oct. 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Yamanashi Gakuin Junior College
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of consuming the test food on sleep
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intake of the test food for 30 days
Interventions/Control_2 - Intake of the placebo food for 4 weeks
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - (1) Healthy men and women aged 18 to 23 years old
(2) Individuals who were determined to be highly likely to have sleep problems based on a sleep questionnaire
(3) Individuals who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.
Key exclusion criteria - (1) Those who are undergoing drug treatment
(2) Those regularly taking items that may affect the results of the test, e.g., medications, food for specified health uses, foods with function claims, and health foods
(3) Those with past or current medical history of serious diseases in organs such as the heart, liver, kidney, or digestive system
(4) Those who are using pacemakers
(5) Those who were pregnant, suspected of being pregnant, or breastfeeding
(6) Those with extremely irregular dietary habits or lifestyle routines
(7) Those who consumed 200 g of onions (at least one onion) per day
(8) Those who have allergies to medications and food and are at risk of causing allergies related to the test food.
(9) Those diagnosed with sleep apnea syndrome or who were aware of their apnea condition
(10) Those who are unable to abstain from alcohol or smoking during the test period when samples are collected
(11) Those with a past medical and treatment history of sleeping disorder
(12) Those who are currently undergoing treatment for sleep disorders
(13) Those who plan to participate in another clinical trial after consenting to participate in this study.
(14) Others deemed unsuitable for participation in this study by the principal investigator.
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 23 Day
Anticipated trial start date - 2025 Year 10 Month 30 Day
Last follow-up date - 2026 Year 01 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068159
Disclaimer: Curated by HT Syndication.
