Healthy older adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Tokyo Metropolitan Institute for Geriatrics and Gerontology Research Team for Promoting Independence and Mental Health