Tokyo, Sept. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063070) titled 'Study on the effects of consumption of the test food on sleep in healthy Japanese' on Sept. 28.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - Placebo

Primary Sponsor: Institute - Mizkan Holdings Co. Ltd.

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effects of consumption of the test food on sleep quality in healthy Japanese. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: Four weeks Test product: Intervention food Interventions/Control_2 - Duration: Four weeks Test product: Placebo

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Individuals aged 20 or more and less than 65

4. Healthy individuals

5. Individuals whose mean standardized score (Zi) of the five factors of the OSA-MA is < 50

6. Individuals whose mean standardized score (Zi) of "Initiation and maintenance of sleep" of the OSA-MA is < 50 Key exclusion criteria - Individuals who 1. are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction

2. have an implanted pacemaker or implantable cardioverter defibrillator

3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. consume Foods for Specified Health Uses or Foods with Functional Claims

5. are taking or using medications (including herbal medicines) or supplements, particularly those who regularly use anticoagulants such as warfarin

6. are allergic to medications or foods related to the test product (particularly, intervention food, placebo, or wheat)

7. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues

8. have irregular sleeping time or habit due to work such as a late-night shift

9. have irregular lifestyles (such as diet, exercise, and sleep)

10. sleep in a bed shared with multiple people

11. are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome

12. work in physical labor such as transportation of heavy objects

13. cannot consume intervention food or placebo every day

14. consume intervention food and related foods at least four days per week

15. take food/beverage containing functional ingredients which may influence sleep quality

16. have allergy symptoms caused by pollen and regularly use medications

17. are pregnant, lactating, or planning pregnancy during this study

18. have participated in other clinical studies within 28 days before informed consent, or plan to participate in another study during this study

19. are deemed unsuitable for participation in this study by the principal investigator Target Size - 60

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 09 Month 09 Day Date of IRB - 2026 Year 09 Month 09 Day Anticipated trial start date - 2026 Year 09 Month 28 Day Last follow-up date - 2027 Year 02 Month 19 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072198

Disclaimer: Curated by HT Syndication.