UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039527 |
|---|---|
| Receipt number | R000045078 |
| Scientific Title | Safety assessment of the Yeast Extract containing nicotinamide mononucleotide (NMN) |
| Date of disclosure of the study information | 2020/02/18 |
| Last modified on | 2020/02/18 18:54:08 |
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Basic information
Public title
Safety assessment of the Yeast Extract containing nicotinamide mononucleotide (NMN)
Acronym
Safety of Yeast Extract containing NMN
Scientific Title
Safety assessment of the Yeast Extract containing nicotinamide mononucleotide (NMN)
Scientific Title:Acronym
Safety of Yeast Extract containing NMN
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluatee the safety of the Yeast Extract containing nicotinamide mononuc leotide (NMN)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety assessment
(1) Physical measurements
height, weight, body fat percentage, BMI, systolic blood pressure, diastolic blood pressure, heart rate
(2) Blood test
hematology: white blood cell count, red blood cell count, hemoglobin, Hematocrit, platelet count, MCV, MCH, MCHC
b. Biochemical tests: TG, total cholesterol, LDL-cholesterol, HDL-cholesterol, free fatty acid, acetoacetic acid, 3-hydroxyacetic acid, total ketone body , lipoprotein (a), glucose, HbA1c, insulin, AST , AL T, gamma-GTP, ALP, LDH, total protein, albumin, uric acid, urea nitrogen, creatinine, sodium, chloride, potassium, calcium, inorganic phosphorus, magnesium
(3) Urine testing
Sugar, protein, urobilinogen, ketone body, pH, specific gravity, occult blood reaction, bilirubin, sediment (when protein is positive)
(4) Diary
Key secondary outcomes
Assessment the NAD-related metabolites in blood
Blood NAD,NMN,nicotinamide,NA,NR,NAR,NAMN,NAAD
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Test Food 1: 10% Yeast extract containing NMN 2.5 g/day (24 tablets twice at morning and evening) for 12 weeks
Interventions/Control_2
Test Food 2: placebo (Dextran) at 2.5 g/day for 12 weeks.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese volunteer with age between 20 and 65
2. Qualified person judged by medical doctor based on the results of clinical laboratory test:
TG, LDL-cholesterol, fasting glucose, HbA1c, AST, ALT, gamma-GTP, Serum amylase, Creatinine
Key exclusion criteria
1. Person with past treatment history of malignant tumor, heart failure, or myocardial infarction.
2. Person currently under treatment for atrial fibrillation, arrhythmia, hepatic dysfunction, renal dysfunction, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, or other chronic diseases.3. Person with medication (including Kampo medicine).
4. Person with allergy against medicine or the test food
5. Pregnant, unwilling to practice contraception during the study, or lactating female
6. Person who is not judged as not qualified by the medical doctor.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Nakagawa |
| Middle name | |
| Last name | Takashi |
Organization
University of Toyama
Division name
Faculty of Medicine, Department of Molecular and Medical Pharmacology
Zip code
930-0194
Address
2630 Sugitani, Toyama
TEL
076-434-7262
nakagawa@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Nakagawa |
| Middle name | |
| Last name | Takashi |
Organization
University of Toyama
Division name
Faculty of Medicine, Department of Molecular and Medical Pharmacology
Zip code
930-0194
Address
2630 Sugitani, Toyama
TEL
076-434-7262
Homepage URL
nakagawa@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Corporation Life Sciences Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board, University of Toyama
Address
2630 Sugitani, Toyama
Tel
076-415-8857
rinken@adm.u-toyama.ac.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
| 2020 | Year | 02 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
0
Results
This clinical trial is terminated.
Results date posted
| 2020 | Year | 02 | Month | 18 | Day |
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
Terminated
Date of protocol fixation
| 2019 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2019 | 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
| 2020 | Year | 02 | Month | 18 | Day |
Last modified on
| 2020 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045078
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
