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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name