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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036321
Receipt No. R000040733
Scientific Title Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effect of nicotinamide mononucleotide (NMN) on the body composition in elderly persons
Date of disclosure of the study information 2019/06/01
Last modified on 2019/06/27

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Basic information
Public title Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effect of nicotinamide mononucleotide (NMN) on the body composition in elderly persons
Acronym The study to evaluate the effect of nicotinamide mononucleotide (NMN) on the body composition in elderly persons
Scientific Title Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effect of nicotinamide mononucleotide (NMN) on the body composition in elderly persons
Scientific Title:Acronym The study to evaluate the effect of nicotinamide mononucleotide (NMN) on the body composition in elderly persons
Region
Japan

Condition
Condition healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of NMN oral administration on the body composition in elderly persons
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate the skeletal muscle index by the bioelectrical impedance analysis
Key secondary outcomes 1) To evaluate the parameters related to glucose metabolism
2)To evaluate the vascular endothelial function by FMD

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 Subjects receive 250 mg/day of NMN for 12 weeks.
Interventions/Control_2 Subjects receive placebo 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
65 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1)the healthy subjects who agree to the study.
2)Body Mass Index 22-28
3)no smoking history
Key exclusion criteria 1)The subjects who take functional food that may affect the trial
2)The subjects who take more than one hour daily exercise for more than 6 months
3)The subjects with the history of serious disease (malignant neoplasms, cardiac failure and myocardial infarction )
4)The subjects with chronic disease
5)The subjects who take medicines
6)The subjects with allergic disorders.
7)The subjects who participate in any clinical trial within 90 days of the commencement of the trial
8)The subjects judged as ineligible by clinical investigators
Target sample size 42

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Igarashi
Organization The Unversity of Tokyo Hospital
Division name Department of Diabetes and Metabolic Diseases
Zip code 113-8655
Address 7-3-1 Hongo Bunkyo-ku
TEL 03-3815-5411
Email igarashi-tky@umin.ac.jp

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Igarashi
Organization The University of Tokyo Hospital
Division name Department of Diabetes and Metabolic Diseases
Zip code 113-8655
Address 7-3-1 Hongo Bunkyo-ku
TEL 03-3815-5411
Homepage URL
Email igarashi-tky@umin.ac.jp

Sponsor
Institute Department of Diabetes and Metabolic Diseases, The University of Tokyo Hospital
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 The University of Tokyo, Clinical Research Review Board
Address 7-3-1 Hongo Bunkyo-ku
Tel 03-5841-0818
Email ethics@m.u-tokyo.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
2019 Year 06 Month 01 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
2019 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 27 Day
Last modified on
2019 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040733

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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