An exploratory clinical trial on the effects of nicotinamide mononucleotide (NMN) intake and exercise on skeletal muscle mass and function in older adults.

UMIN ID: UMIN000054187

Registered date:19/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Healthy older adults
• Date of first enrollment: 2024/04/22
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: 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.
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Tokyo Metropolitan Institute for Geriatrics and Gerontology
• Source(s) of Monetary Support: Mitsubishi Corporation Life Sciences Limited