UMIN-CTR Clinical Trial

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
Email	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
Email	nakagawa@med.u-toyama.ac.jp

Sponsor
Institute	University of Toyama
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045078