Slow Age: a Randomized, Controlled Clinical Trial of Interventions to Slow Aging in Humans
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Interleukin-6 levels in plasma
研究概览
简要总结
The proportion of older individuals is growing, and it is therefore important to investigate ways to promote healthy aging. Exercise is one of the most studied interventions and is known to have a variety of health benefits. Dietary interventions have also shown encouraging results, with intermittent fasting being a promising anti-aging intervention. Likewise, dietary supplementation with precursors that can increase the central metabolite nicotinamide dinucleotide (NAD+) has powerful effects on aging at least in model organisms. Although physical exercise is known to increase health-span, the effects of these latter dietary interventions on aging lacks evidence in humans.
This is a randomized, controlled trial of interventions to slow aging in humans. Healthy older individuals will be randomized into either an aerobic exercise (EXE), time-restricted feeding (TRF), nicotinamide riboside (NR), or control group and followed for twelve weeks. Changes in biomarkers of aging will be assessed before and after the intervention. It is hypothesized that the interventions provide similar, superior benefits to these markers when compared to placebo.
Primary Outcome: Interleukin-6 levels. Secondary Outcomes: CRP, TNF-α, NAD+, hematologic age, epigenetic age (DNA methylation), transcriptomic age (RNA-sequencing), functional age (handgrip strength, gait speed), body composition, vocal age, and photo age
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Aged ≥ 65 years
- •In good general health
排除标准
- •Inability or unwillingness to take oral supplements
- •Inability or unwillingness to adhere to the fasting regiment
- •Inability or unwillingness to perform the prescribed physical exercise
- •Current smoker or use of any nicotine products within 10 years
- •Chronic use of supplements containing vitamin B or nicotinamide riboside
- •Treatment with another investigational drug or other intervention within 1 year
- •Cancer diagnosis within last 5 years
研究组 & 干预措施
Exercise arm
12 week aerobic exercise will be performed in agreement with current guidelines for exercise in older adults from the American College of Sports Medicine. A frequency of 5 days/week, totaling 150-300 min/week, performed at both moderate and vigorous intensities is chosen. This dose has a high level of evidence supporting positive effects on health- and life-span.
干预措施: Exercise (Behavioral)
Time restricted feeding
A 12 week fasting/feeding regiment of 16 hours fasting /8 hours feeding each day is chosen. This ratio has been shown to be tolerable in older individuals.
干预措施: Time restricted feeding (Behavioral)
Control
A control group with no intervention.
Nicotinamide riboside
Previous clinical trials have shown that an nicotinamide riboside dose up to 2 g/day is well tolerated with no treatment-emergent adverse events reported so far and with efficacy on our primary outcome measurement. A dose of 2 g/day NR is therefore chosen and will be split in two: 1 g in the morning and 1 g in the evening.
干预措施: Nicotinamide riboside (Dietary Supplement)
结局指标
主要结局
Interleukin-6 levels in plasma
时间窗: Day 1 compared to day 84
次要结局
- Predicted age (DNA methylation)(Day 1 compared to day 84)
- Concentration of CRP in plasma(Day 1 compared to day 84)
- Concentration of TNF-α in plasma(Day 1 compared to day 84)
- Concentration of NAD in whole blood(Day 1 compared to day 84)
- Change in fat mass(Day 1 compared to day 84)
- Change in lean mass(Day 1 compared to day 84)
- Grip strength(Day 1 compared to day 84)
- Gait speed(Day 1 compared to day 84)
- Predicted age (photo)(Day 1 compared to day 84)
- Predicted age (Blood age)(Day 1 compared to day 84)
- Predicted age (Transcriptomics)(Day 1 compared to day 84)
- Predicted age (voice)(Day 1 compared to day 84)