Hypertension, Pre Hypertension
Conditions
Keywords
vascular stiffness, blood pressure, vascular function
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTDietary capsules
Daily doses of dietary capsaicin or placebo in capsule form
Sponsors
American Heart Association
Skidmore College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The capsules will be placed into solid white color bottles, and labeled discreetly by a third party not directly involved with the research.
Intervention model description
Parallel: Participants are randomly assigned to one of two groups in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* relatively healthy (other than elevated blood pressure) non-smoking men and women over the age of 18 from the local community
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate (HR) and HR variability (HRV) | 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. |
| Passive Leg Movement Hyperemia | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Lipids | Baseline and 6-weeks | The investigators will collect blood to determine blood lipids (cholesterol) and glucose. |
| Urinary Capsaicinoids | Baseline, 24 hours, and 6-weeks | The investigators will collect urine to determine urinary capsaicin and associated metabolites to understand bioavailability and potential relation to function. |
Countries
United States
Contacts
Primary ContactStephen Ives, PhD
Outcome results
None listed