Effects of Exercise Training Intensity and Inorganic Nitrate Supplementation on Vascular Health and Fitness in Post-Menopausal Females
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Cardiorespiratory Fitness
研究概览
简要总结
Menopause greatly increases cardiovascular disease risk (CVD). Current exercise guidelines are inadequate to ameliorate this risk and higher intensity exercise may be necessary for cardiovascular benefits in postmenopausal females. Oral nitrate supplementation enhances exercise performance and CVD risk profile in several clinical conditions. The investigators recently reported that 3-days of nitrate supplementation in postmenopausal females enhances acute post-exercise vascular function, in an intensity dependent manner. The effects of nitrate supplementation and exercise training over a longer training program remains unexplored. This investigation will examine the impact of exercise training intensity with and without inorganic nitrate supplementation, on CVD and fitness outcomes. Postmenopausal females will be tested for maximal oxygen uptake and lactate threshold before randomization to one of four groups: that inorganic nitrate-rich beetroot juice, or beetroot juice with nitrate extracted; and assigned to one-month of calorie matched high-intensity or moderate-intensity exercise training. Vascular function and fitness will be evaluated before and after training.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A study team member not associated with the trial will perform the randomization scheme for the supplementation. Exercise groups will not be blinded but data will not be analyzed until the end or re-labeled by another team member so assessors are unaware while analyzing the data.
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Post-menopausal female (greater than age 45 but less than age 75)
- •Sedentary (does not exercise regularly or less than 2 bouts of exercise per week)
- •No major changes in medication in the last 3 months
排除标准
- •Smokers within last 5 years
- •Weight unstable (loss/gain of more than 3kg in the past 3 months)
- •Any medical condition that prevents the subject from exercising safely
- •Hormone replacement therapy (current or within last 3 months)
- •Currently or recently on vasoactive medications (i.e., calcium channel blockers, statins, ACE or renin inhibitors, ARBs, nitrates, alpha- or beta-blockers, diuretics, proton pump inhibitors, etc.)
- •Oral antibiotic use within previous four weeks
- •Oral disease or poor oral health as determined by the Oral Health Questionnaire
- •Using an antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use
研究组 & 干预措施
Nitrate-Rich Beetroot Juice + High Intensity Exercise (HIE)
Participants assigned to this group will be instructed to consume 1 bottle of nitrate-rich beetroot juice (~400mg of nitrate each) 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 15-17 based on the participant's VO2peak test.
干预措施: Nitrate-Rich Beetroot Juice (Dietary Supplement)
Nitrate-Rich Beetroot Juice + High Intensity Exercise (HIE)
Participants assigned to this group will be instructed to consume 1 bottle of nitrate-rich beetroot juice (~400mg of nitrate each) 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 15-17 based on the participant's VO2peak test.
干预措施: High Intensity Exercise (Behavioral)
Nitrate-Depleted Placebo Beetroot Juice + High Intensity Exercise (HIE)
Participants assigned to this group will be instructed to consume 1 bottle of nitrate-depleted beetroot juice 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 15-17 based on the participant's VO2peak test.
干预措施: High Intensity Exercise (Behavioral)
Nitrate-Depleted Placebo Beetroot Juice + High Intensity Exercise (HIE)
Participants assigned to this group will be instructed to consume 1 bottle of nitrate-depleted beetroot juice 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 15-17 based on the participant's VO2peak test.
干预措施: Nitrate-Depleted Placebo Beetroot Juice (Dietary Supplement)
Nitrate-Rich Beetroot Juice + Moderate Intensity Exercise (MIE)
Participants assigned to this group will be instructed to consume 1 bottle of nitrate-rich beetroot juice (~400mg of nitrate each) 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 10-12 based on the participant's VO2peak test.
干预措施: Nitrate-Rich Beetroot Juice (Dietary Supplement)
Nitrate-Rich Beetroot Juice + Moderate Intensity Exercise (MIE)
Participants assigned to this group will be instructed to consume 1 bottle of nitrate-rich beetroot juice (~400mg of nitrate each) 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 10-12 based on the participant's VO2peak test.
干预措施: Moderate Intensity Exercise (Behavioral)
Nitrate-Depleted Placebo Beetroot Juice + Moderate Intensity Exercise (MIE)
Participants assigned to this group will be instructed to consume 1 bottle of nitrate-depleted beetroot juice 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 10-12 based on the participant's VO2peak test.
干预措施: Moderate Intensity Exercise (Behavioral)
Nitrate-Depleted Placebo Beetroot Juice + Moderate Intensity Exercise (MIE)
Participants assigned to this group will be instructed to consume 1 bottle of nitrate-depleted beetroot juice 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 10-12 based on the participant's VO2peak test.
干预措施: Nitrate-Depleted Placebo Beetroot Juice (Dietary Supplement)
结局指标
主要结局
Cardiorespiratory Fitness
时间窗: Baseline and after 1-month of exercise training
Peak aerobic capacity (VO2peak) will be assessed using a symptom-limited graded exercise test on a treadmill. An IV will be placed and lactate measured during rest and after the completion of every 3-minute stage to determine lactate threshold at VO2peak.
Vascular Endothelial Function (Flow-Mediated Dilation [FMD])
时间窗: Baseline and after 1-month of exercise training
Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The arteries will be imaged using a high-resolution 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 3 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle.
次要结局
- Oral Nitrate Reducing Capacity(Baseline and after 1-month of exercise training)
- Skeletal muscle perfusion(Baseline and after 1-month of exercise training)
- Peripheral and Central Blood Pressures(Baseline and after 1-month of exercise training)
- 24-hour ambulatory blood pressure(Baseline and after 1-month of exercise training)
- Skeletal muscle microvascular perfusion (near-infra-red- spectroscopy)(Baseline and after 1-month of exercise training)
- Hemoglobin(Baseline and after 1-month of exercise training)
- Plasma Nitrate(Baseline and after 1-month of exercise training)
- Plasma Nitrite(Baseline and after 1-month of exercise training)
- Oral Nitrate Reducing Capacity(Baseline and after 1-month of exercise training)
- Skeletal muscle perfusion(Baseline and after 1-month of exercise training)
- Peripheral and Central Blood Pressures(Baseline and after 1-month of exercise training)
- 24-hour ambulatory blood pressure(Baseline and after 1-month of exercise training)
- Skeletal muscle microvascular perfusion (near-infra-red- spectroscopy)(Baseline and after 1-month of exercise training)
- Lipids(Baseline)
- Hemoglobin(Baseline and after 1-month of exercise training)
- Plasma Nitrate(Baseline and after 1-month of exercise training)
- Plasma Nitrite(Baseline and after 1-month of exercise training)
研究者
Jason Allen
Professor
University of Virginia