Tokyo, Nov. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059690) titled 'Effects of test food consumption on sleep in healthy Japanese' on Nov. 7.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Yotsuba Milk Products Co., Ltd.

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

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

Intervention: Interventions/Control_1 - Duration: Eight weeks Test product: Capsule containing Lactococcus cremoris subsp. cremoris YRC3780 powder Administration: Take one capsule with water without chewing per day.

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day. Interventions/Control_2 - Duration: Eight weeks Test product: Capsule not containing Lactococcus cremoris subsp. cremoris YRC3780 powder Administration: Take one capsule with water without chewing per day.

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals among those who provided informed consent, met inclusion criteria No. 1~4, and did not meet any of the exclusion criteria, whose AIS score is six or higher at screening Key exclusion criteria - Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. have a pacemaker or an implantable cardioverter defibrillator (ICD)

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. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. are taking or using medications (including herbal medicines) or supplements

6. are allergic to medicines or foods related to the test product

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. live with their infants less than one year old

10. sleep with their children (1 to 6 years old)

11. live with requiring long-term care persons

12. sleep with more than one person

13. have nocturia three times or more

14. drink to excess (average of more than about 20 g/day as pure alcohol intake)

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

16. are undergoing medical treatment for chronic fatigue syndrome, menopausal syndrome, sleep apnea syndrome, or any other sleep disorders

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

18. are undergoing medical treatment or have a medical history of sleep disorder or sleep apnea syndrome

19. Individuals who are pregnant, lactating, or planning to become pregnant during this study

20. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

21. are judged as ineligible to participate in this study by the physician Target Size - 100

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 22 Day Date of IRB - 2025 Year 10 Month 22 Day Anticipated trial start date - 2025 Year 11 Month 07 Day Last follow-up date - 2026 Year 04 Month 27 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068275

Disclaimer: Curated by HT Syndication.