Unique ID issued by UMIN | UMIN000054187 |
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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 |
An exploratory clinical trial on the effects of nicotinamide mononucleotide (NMN) intake and exercise on skeletal muscle mass and function in older adults.
Effects of nicotinamide mononucleotide (NMN) intake and exercise on skeletal muscle in older adults.
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.
An exploratory clinical trial on the effects of nicotinamide mononucleotide (NMN) intake and exercise on skeletal muscle in older adults.
Japan |
Healthy older adults
Adult |
Others
NO
The purpose of this study is to explore the effects of NMN intake and exercises on skeletal muscle mass and function in older adults.
Efficacy
Exploratory
Not applicable
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.
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food | Behavior,custom |
1).Subjects receive of NMN for 24 weeks.
2).Subjects will receive strength training for 24 weeks.
1).Subjects receive placebo for 24 weeks.
2).Subjects will receive strength training for 24 weeks.
65 | years-old | <= |
Not applicable |
Male and Female
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.
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.
70
1st name | Takashi |
Middle name | |
Last name | Shida |
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Research Team for Promoting Independence and Mental Health
173-0015
35-2, Sakae-cho, Itabashi-ku, Tokyo
03-3964-3241
t_shida@tmig.or.jp
1st name | Takashi |
Middle name | |
Last name | Shida |
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Research Team for Promoting Independence and Mental Health
173-0015
35-2, Sakae-cho, Itabashi-ku, Tokyo
03-3964-3241
t_shida@tmig.or.jp
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Mitsubishi Corporation Life Sciences Limited
Profit organization
Japan
Tokyo Metropolitan Institute for Geriatrics and Gerontology Institutional Review Board
35-2, Sakae-cho, Itabashi-ku, Tokyo
03-3964-3241
rinsyoushiken@tmghig.jp
NO
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)
2024 | Year | 04 | Month | 19 | Day |
Unpublished
Preinitiation
2024 | Year | 02 | Month | 15 | Day |
2024 | Year | 02 | Month | 15 | Day |
2024 | Year | 04 | Month | 22 | Day |
2026 | Year | 12 | Month | 31 | Day |
2024 | Year | 04 | Month | 18 | Day |
2024 | Year | 04 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061872
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