Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04691986
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2020-12-10
Brief Title:
Impacts of Nicotinamide Riboside on Functional Capacity and Muscle Physiology in Older Veterans
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Impacts of Nicotinamide Riboside on Functional Capacity and Muscle Physiology in Older Veterans
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NR-VET
Brief Summary:
Frailty is an age-associated clinical condition of poor physiological reserve that increases risks for falls hospitalization and mortality Nicotinamide adenine dinucleotide NAD is a critical co-factor needed for many cellular processes The natural levels of NAD decline aging and this has been linked to physical performance decline in animals Human trials have demonstrated that nicotinamide riboside NR a form of vitamin B3 is safe and effectively increases NAD levels In animal studies NR improves treadmill performance and muscle quality Here the investigators propose a double-blind randomized control trial to assess the benefits of NR supplementation on human muscle function and physiology The investigators anticipate the research findings will support the use of this nutritional supplement to improve the health of Veterans during aging
Detailed Description:
Frailty is increasingly seen within the aging population and is driven largely by musculoskeletal declines Nearly 9 million Veterans are now 65 years of age or older with impairments in functional capacity reduction in quality of life and an increase in the use of health care services and associated costs An estimated 45-50 of those over the age of 85 are frail which could represent well over 1 million Veterans Aging which significantly contributes to frailty is highly correlated with reduced levels of nicotinamide adenine dinucleotide NAD an essential mediator in mitochondrial function Restoration of cellular NAD levels is gaining support as a therapeutic strategy to maintain and even enhance functional capacity during aging Nicotinamide riboside NR - an NAD precursor - enhances physical activity and mitochondrial health in mice Furthermore NR was recently shown to be safe in human clinical trials for boosting NAD yet the benefits for human physical performance and muscle physiology are unknown Therefore the goal of this project is to establish a double-blind randomized control trial to assess the impacts of NR on functional capacity muscle function and structure and mRNA signaling in healthy older adults Towards this goal this study will investigate healthy older individuals between the ages of 65 and 85 who will receive NR or a placebo for a period of 3 months Participants will be tested for frailty gait speed and muscle strength at each time point Additionally muscle biopsies and serum will be collected to assess changes in muscle fiber histology mitochondrial biomass and activity and mRNA profiles This project will provide greater insight into NR supplementation as a therapeutic strategy to stave off frailty and maintain resilience during aging
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RX003396 | OTHER_GRANT | VA RRD Service | None |