UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059201 |
|---|---|
| Receipt number | R000067710 |
| Scientific Title | Clinical study investigating the effects of NMN/garlic extract supplements on sleep |
| Date of disclosure of the study information | 2025/09/26 |
| Last modified on | 2025/09/26 13:57:04 |
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Basic information
Public title
Clinical study investigating the effects of NMN/garlic extract supplements on sleep
Acronym
Clinical study investigating the effects of NMN/garlic extract supplements on sleep
Scientific Title
Clinical study investigating the effects of NMN/garlic extract supplements on sleep
Scientific Title:Acronym
Clinical study investigating the effects of NMN/garlic extract supplements on sleep
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Psychiatry | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep EEG
Key secondary outcomes
Plasma NAD+ synthesis-related component concentrations
Plasma NAD+ synthesis-related activity
OSA Sleep Questionnaire MA Version
Blood Biochemistry Tests
Blood pressure
Pulse rate
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 65 | 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 sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Hirohito |
| Middle name | |
| Last name | Ishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
ishikawa@hc-sys.jp
Public contact
Name of contact person
| 1st name | Hirohito |
| Middle name | |
| Last name | Ishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
0368092722
Homepage URL
ishikawa@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
LongGen Bioscience Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Institute for Research on Productive Aging; IRPA
S'UIMIN Co., Ltd.
Bizen Kasei Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067710
