UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056177 |
|---|---|
| Receipt number | R000064194 |
| Scientific Title | Study on single oral intake of processed garlic food in healthy subjects |
| Date of disclosure of the study information | 2024/11/18 |
| Last modified on | 2025/05/19 09:26:48 |
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Basic information
Public title
Study on single oral intake of processed garlic food in healthy subjects
Acronym
Study on single oral intake of processed garlic food in healthy subjects
Scientific Title
Study on single oral intake of processed garlic food in healthy subjects
Scientific Title:Acronym
Study on single oral intake of processed garlic food in healthy subjects
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of a single intake of a supplement containing garlic-derived ingredients on blood NAD+ synthesis-related components in Japanese adult males and females aged 20 to 49 years old in an exploratory manner.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma NAD+ synthesis-related component concentrations, and plasma NAD+ synthesis-related activity
Key secondary outcomes
Plasma garlic processed food-derived component concentrations
Blood Biochemistry Tests
Blood pressure
Pulse rate
Base
Study type
Interventional
Study design
Basic design
Parallel
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
In this study, the participants consume a specified standard diet for dinner on the day before the study and breakfast on the day of the study. On the day of the study, a single tablet of a supplement containing garlic-derived ingredients is taken with mineral water, and blood samples are taken 0, 0.5, 1, and 2 hours after intake.
Interventions/Control_2
In this study, the participants consume a specified standard diet for dinner on the day before the study and breakfast on the day of the study. On the day of the study, a single tablet of placebo food is taken with mineral water, and blood samples are taken 0, 0.5, 1, and 2 hours after intake.
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
| 20 | years-old | <= |
Age-upper limit
| 49 | 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 male and female between the ages of 20 and 49 at the time of consent
Key exclusion criteria
1.Persons with severe gastrointestinal, hepatic, renal, circulatory, hematological, endocrine, or malignant neoplasm, or suspected or existing malignant neoplasm
2.Persons with a BMI of 30 or higher
3.Women who are menstruating or menopausal
4.Persons are allergic to standard foods and test foods
5.Persons who usually take medicine, specified health food, healthy food and supplements containing NAD intermediate metabolites (complex vitamins, nicotinamide mononucleotide (NMN))
6.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
7.Persons who were judged as inappropriate for study participants by the principal investigator
8.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size
40
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
03-6809-2722
Homepage URL
ishikawa@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Wakunaga Pharmaceutical 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
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, 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
| 2024 | Year | 11 | Month | 18 | 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
40
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
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064194
