Impacts of Nicotinamide Riboside on Functional Capacity and Muscle Physiology in Older Veterans
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Sub-maximal oxygen uptake test (VO2max)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The study design participants, care providers, and investigators will be blinded to the group designation of the participants. To accomplish this, the study statistician will coordinate with the VA pharmacy to assign groups to participants and to dispense appropriate treatments to the study coordinator to give to study participants.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 65-85
- •Male or female
- •Ability to use an exercise bike
- •Medically cleared for muscle biopsy
排除标准
- •Severe Co-morbidity
- •examples include, but not limited to:
- •congestive heart failure class equal to or above III
- •chronic obstructive pulmonary disorder (COPD) gold stage IV
- •chronic kidney disease equal to or above stage
- •A VA-SLUMS cognitive screen score of less than or equal to 20
- •Body mass index greater than or equal to 40
研究组 & 干预措施
NR Supplementation
Participants in this group will receive NR supplementation at 1000 mg per day (given as 2x250mg capsules morning and 2x250mg at night).
干预措施: Nicotinamide Riboside (Dietary Supplement)
Placebo supplementation
Participants in this group will receive placebo given as 2 pills in the morning and 2 pills at night. Placebo pills contain micro cellulose which is likewise found in NR containing capsules.
干预措施: Placebo (Other)
结局指标
主要结局
Sub-maximal oxygen uptake test (VO2max)
时间窗: Change from baseline to endpoint at 12 weeks
Participants are asked to exercise on an recumbent exercise bike as the resistance increases over time. During the exercise, participants are asked to breath through a mask that is connected to a oxygen and carbon dioxide measuring device. Participant will be asked to continue until they report exhaustion, reach 85% of heart rate maximum, or if there are medical concerns. The assessment last for approximately 15 minutes and provides data the pertain to an individuals lung capacity, breathing rate, and endurance.
Muscle strength
时间窗: Change from baseline to endpoint at 12 weeks
Leg and arm strength will be measured using a small handheld dynamometer where the device is placed on the wrist or ankle as the participant is asked to extend or contract the limb with full force.
Gait speed
时间窗: Change from baseline to endpoint at 12 weeks
Participants are asked to perform a timed walk of approximately 15 feet in length
次要结局
- Frailty assessment(Change from baseline to endpoint at 12 weeks)
- Short Physical Performance Battery(Change from baseline to endpoint at 12 weeks)
- Quality of life assessment(Change from baseline to endpoint at 12 weeks)
- Cognitive screen(Change from baseline to endpoint at 12 weeks)
- Serum inflammatory biomarkers(Change from baseline to endpoint at 12 weeks)
- Body Composition (Lean and fat mass)(Change from baseline to endpoint at 12 weeks)
- Blood occlusion resilience(Change from baseline to endpoint at 12 weeks)
- 6-minute walk and heart rate recovery(Change from baseline to endpoint at 12 weeks)
- Balance resistance(Change from baseline to endpoint at 12 weeks)