UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054187 |
|---|---|
| Receipt number | R000061872 |
| Scientific Title | An exploratory clinical trial on the effects of nicotinamide mononucleotide (NMN) intake and exercises on skeletal muscle mass and function in older adults with reduced skeletal muscle mass. |
| Date of disclosure of the study information | 2024/04/19 |
| Last modified on | 2024/04/23 17:34:08 |
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Basic information
Public title
An exploratory clinical trial on the effects of nicotinamide mononucleotide (NMN) intake and exercise on skeletal muscle mass and function in older adults.
Acronym
Effects of nicotinamide mononucleotide (NMN) intake and exercise on skeletal muscle in older adults.
Scientific Title
An exploratory clinical trial on the effects of nicotinamide mononucleotide (NMN) intake and exercises on skeletal muscle mass and function in older adults with reduced skeletal muscle mass.
Scientific Title:Acronym
An exploratory clinical trial on the effects of nicotinamide mononucleotide (NMN) intake and exercise on skeletal muscle in older adults.
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore the effects of NMN intake and exercises on skeletal muscle mass and function in older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in skeletal muscle mass (as measured by CT images), grip strength, and isometric knee extension strength at the final evaluation, following a 24-week intervention period from the baseline.
Key secondary outcomes
1).NAD metabolites-related items in blood
2).Muscle thickness, echo intensity, and muscle stiffness in the thigh and lower leg by ultrasonography
3).The rising isometric knee extension strength waveform
4).Physical function and chair stand
5).Skeletal muscle-related items in blood
6).Oxidative stress-related items in blood
7).Physical activity
8).Pittsburgh sleep quality index
9).Cognitive functions
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 | Behavior,custom |
Interventions/Control_1
1).Subjects receive of NMN for 24 weeks.
2).Subjects will receive strength training for 24 weeks.
Interventions/Control_2
1).Subjects receive placebo for 24 weeks.
2).Subjects will receive strength training for 24 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 and Female
Key inclusion criteria
1).Participants who have consented to the content regarding this study.
2).Participants who had reduced muscle mass (skeletal muscle index less than 7.0 kg/m2 in men and 5.7 kg/m2 in women at screening)
3).Persons deemed appropriate by the clinical investigator to participate in this study.
Key exclusion criteria
1).The subjects with a history of heart failure, neurodegenerative disease, or Parkinson's disease.
2).The subjects undergoing treatment for malignancy, atrial fibrillation, arrhythmias, hepatic disorders, renal disorders, cerebrovascular disorders, rheumatism, diabetes mellitus, or other chronic diseases.
3).The subjects undergoing treatment for sleep disorders (insomnia), depression or other psychiatric disorders.
4).The subjects with dementia or an MMSE (Mini-Mental State Examination) score of less than 23 points.
5).The subjects who may develop allergic symptoms to the test food (vitamins), or to any other food or drug.
6).The subjects who habitually consume food supplements or nutritional/energy drinks containing NMN or niacin (vitamin B3, nicotinamide, nicotinic acid amide).
7).The subjects who habitually take medicines, specified health foods, or health foods that may affect aging, such as drugs with antioxidant properties.
8).The subjects who are prohibited from exercising by a physician.
9).Currently, subjects who are participating in another clinical trial, have participated in another clinical trial within the past 3 months, or may participate in another trial during the duration of this trial.
10).The subjects who are known in advance to be unable to attend exercise classes on a regular basis (at least 5 out of 8 times a month).
11).The subjects who are judged to have difficulty communicating in Japanese.
12).The subjects deemed ineligible by the clinical investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Shida |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
t_shida@tmig.or.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Shida |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
t_shida@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Corporation Life Sciences Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology Institutional Review Board
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-3241
rinsyoushiken@tmghig.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
東京都健康長寿医療センター研究所（東京都）/Tokyo Metropolitan Institute for Geriatrics and Gerontology (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 19 | 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
| 2024 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2026 | 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 | 04 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061872
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| Registered date | File name |
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