An interventional study of Dietary capsules in Pre Hypertension and Hypertension, sponsored by Skidmore College. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-10.
Sponsored by Skidmore College · Not applicable, Interventional, and Basic science
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.
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.
151 studies on the registry are indexed under Prehypertension; 22 are open to participants now.
This study's planned enrollment of 80 is above the median of 64 across 133 interventional studies indexed under Prehypertension.
Browse Prehypertension studies →Skidmore College is the lead sponsor of 18 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Over-the-counter dose of 2 x 440 mg capsules (880 mg, Capsicum Pepper Blend, Daily Manufacturing, Rockwell, North Carolina, USA)
Dietary Supplement: Dietary capsules
The placebo will be 2 x 400-500 mg fiber (800 mg psyllium husk) capsules which were chosen to be of similar appearance (size, coloration, and texture).
Dietary Supplement: Dietary capsules
Daily doses of dietary capsaicin or placebo in capsule form
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-weeks
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-weeks
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-weeks
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-weeks
Near Infrared Spectroscopy (NIRS) Vascular Occlusion Test
The investigators will assess the metabolic capacity and vascular reactivity using ischemia-reperfusion and NIRS
Time frame: Baseline, 24 hours, and 6-weeks
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-weeks
Blood Lipids
The investigators will collect blood to determine blood lipids (cholesterol) and glucose.
Time frame: Baseline and 6-weeks
Plan to share: No — Only deidentified data may be shared with the sponsor or research community through appropriate data repositories.
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Dec 2025, 16 months after the start.
Of 55 non-industry interventional studies with no phase under Prehypertension, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 16 months is below that.
Counting every sponsor, half of 60 studies reached it within 20 months; a quarter within 11 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Skidmore College