Impact of Sex in the Effect of Dietary Capsaicin on Cardiovascular Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSkidmore College
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
relatively healthy (other than elevated blood pressure) non-smoking men and women over the age of 18 from the local community
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Dietary capsules
Dietary supplementDaily doses of dietary capsaicin or placebo in capsule form
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Dietary CapsaicinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Blood Pressure and Vascular Stiffness
The investigators will assess peripheral and estimated central blood pressures and vascular stiffness using pulse wave analysis.
Time frame
Baseline, 24 hours, and 6-weeks2
Heart Rate (HR) and HR variability (HRV)
The investigators will assess HR and HRV using electrocardiogram and standard techniques to determine time and frequency domain estimates of HRV.
Time frame
Baseline, 24 hours, and 6-weeks3
Flow Mediated Dilation
The investigators will assess brachial artery flow-mediated dilation using ischemia-reperfusion and ultrasound doppler to assess the dilatory capacity and reactive hyperemia.
Time frame
Baseline, 24 hours, and 6-weeks4
Passive Leg Movement Hyperemia
The investigators will assess the hyperemic response to passive leg movement using ultrasound doppler.
Time frame
Baseline, 24 hours, and 6-weeksSecondary outcomes
1
Urinary Capsaicinoids
The investigators will collect urine to determine urinary capsaicin and associated metabolites to understand bioavailability and potential relation to function.
Time frame
Baseline, 24 hours, and 6-weeks2
Blood Lipids
The investigators will collect blood to determine blood lipids (cholesterol) and glucose.
Time frame
Baseline and 6-weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Skidmore College
Lead sponsor
American Heart Association
Collaborator
Source ClinicalTrials.gov