Impact of Sex in the Effect of Dietary Capsaicin on Cardiovascular Health: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Passive Leg Movement Hyperemia
研究概览
简要总结
The investigators long-term goal is to better understand novel interventions to promote cardiovascular health in humans. The goal of the proposed research is to investigate whether there is sex-specificity in the effects of dietary capsaicin on mechanisms regulating nitric oxide (NO) bioavailability, its effect on key markers of cardiovascular (CV) health, including BP, macro- and microvascular function, and arterial stiffness. This knowledge will provide critical insight into the effects of dietary capsaicin on CV health and will guide future trials.
详细描述
Specific Aim 1: Determine the sex-specific effects of dietary capsaicin on central and peripheral blood pressure and arterial stiffness. The investigators hypothesize that dietary capsaicin intervention (6 week) will improve BP and arterial stiffness, likely in a sex-dependent manner. The investigators will measure heart rate variability and excretion of capsaicin and metabolites to ascertain bioavailability, and understand the mechanistic role of the autonomic nervous system, in capsaicin's effect on BP.
Specific Aim 2: Assess whether dietary capsaicin effects on vascular function is sex-specific. The investigators hypothesize that dietary capsaicin intervention (6 week) will improve NO bioavailability, through improved redox balance and lowered asymmetric dimethylarginine, thereby improving peripheral vascular function, likely in a sex-dependent manner.
Utilizing a double-blind, randomized, placebo-controlled, design the investigators will investigate whether there is sex-specificity in the effects of a 6-week dietary capsaicin intervention on nitric oxide (NO) bioavailability, BP, vascular function, and arterial stiffness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The capsules will be placed into solid white color bottles, and labeled discreetly by a third party not directly involved with the research.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •relatively healthy (other than elevated blood pressure) non-smoking men and women over the age of 18 from the local community
排除标准
- •Women who are without a period (not due to a birth control method, intrauterine device or menopause), are pregnant, attempting to conceive, or are breastfeeding will be excluded.
- •uncontrolled hypertension
- •Anyone with severe illness or compromised or suppressed immune system (e.g. taking immune suppressants, chronic viral infection or treatment).
- •Any participants with excessive sensitivity to spicy foods or fiber (psyllium husk) will be excluded
- •Participants with food allergies will be excluded
- •Participants who have difficulty swallowing or swallowing pills may be excluded.
- •Participants who suffer from heartburn, hiatal hernia, gastritis, or peptic ulcer disease may be excluded.
结局指标
主要结局
Passive Leg Movement Hyperemia
时间窗: Baseline, 24 hours, and 6-weeks
The investigators will assess the hyperemic response to passive leg movement using ultrasound doppler.
Near Infrared Spectroscopy (NIRS) Vascular Occlusion Test
时间窗: Baseline, 24 hours, and 6-weeks
The investigators will assess the metabolic capacity and vascular reactivity using ischemia-reperfusion and NIRS
Blood Pressure and Vascular Stiffness
时间窗: Baseline, 24 hours, and 6-weeks
The investigators will assess peripheral and estimated central blood pressures and vascular stiffness using pulse wave analysis.
Flow Mediated Dilation
时间窗: Baseline, 24 hours, and 6-weeks
The investigators will assess brachial artery flow-mediated dilation using ischemia-reperfusion and ultrasound doppler to assess the dilatory capacity and reactive hyperemia.
Heart Rate (HR) and HR variability (HRV)
时间窗: Baseline, 24 hours, and 6-weeks
The investigators will assess HR and HRV using electrocardiogram and standard techniques to determine time and frequency domain estimates of HRV.
次要结局
- Blood Lipids(Baseline and 6-weeks)
- Urinary Capsaicinoids(Baseline, 24 hours, and 6-weeks)