Tokyo, Sept. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059201) titled 'Clinical study investigating the effects of NMN/garlic extract supplements on sleep' on Sept. 26.

Study Type: Interventional

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

Primary Sponsor: Institute - Healthcare Systems Co., Ltd.

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

Objective: Narrative objectives1 - Evaluate the effect of a supplement containing NMN/garlic extract on sleep quality when administered continuously for one week to adults aged 40 to 65 years. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - For one week, consume the test food daily between waking and noon. Following the washout period, consume the placebo food daily between waking and noon for one week. On the evening before the test and on the morning of the test day, consume the specified standard meal. Interventions/Control_2 - For one week, consume the placebo food daily between waking and noon. Following the washout period, consume the test food daily between waking and noon for one week. On the evening before the test and on the morning of the test day, consume the specified standard meal.

Eligibility: Age-lower limit - 40 years-old

Gender - Male and Female Key inclusion criteria - 1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2. Japanese adult men and women aged 40 to 65 years at the time of consent. 3. Persons who are attending school, working, or engaged in housework on weekdays and whose daily bedtime and wake-up times do not fluctuate significantly. 4. Persons whose sleep EEG measurements during the screening test show a tendency toward a decrease in total sleep time or the proportion of deep sleep. Key exclusion criteria - 1. Persons who have a severe gastrointestinal, hepatic, renal, cardiovascular, hematological, or endocrine disease, or a suspected malignancy; or have a history of such diseases, are currently hospitalized, or have a present medical history. 2. Persons who have been diagnosed with and received treatment for insomnia. 3. Persons who have been diagnosed with or have a tendency to have sleep apnea syndrome or behavior-induced sleep deprivation syndrome. 4. Persons who have been diagnosed with, or have been diagnosed with, a mood disorder, including depression, and have taken medication. 5. Persons with a BMI of less than 20 or greater than 28. 6. Persons who usually take medicine, specified health food, healthy food and supplements containing NAD intermediate metabolites (complex vitamins, nicotinamide mononucleotide (NMN)) 7. Persons who usually take medicine, specified health food, healthy food and supplements that may affect sleep. 8. Persons who cannot avoid consuming alcohol or caffeine on the day of the sleep EEG measurement. 9. Persons who consume excessive alcohol.* 10. Persons whose usual bed time is less than 6 hours. 11. Persons working shifts, night shifts, or heavy labor. 12. Persons who are breastfeeding, pregnant, or planning or hoping to become pregnant during the study period. 13. Persons living with a caregiver. 14. Persons who cannot sleep alone in a bed or futon during the study period (sleeping with one or more other persons in the same room is permissible). 15. Subjects who are allergic to the standard or test foods. 16. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam 17. Persons who were judged as inappropriate for study participants by the principal investigator *: The standard for excessive consumption is 3 times a week, 1 go (equivalent to 1 cup of sake) or more. Target Size - 22

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 26 Day Date of IRB - 2025 Year 09 Month 26 Day Anticipated trial start date - 2025 Year 09 Month 30 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067710

Disclaimer: Curated by HT Syndication.