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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Capsaicin | Experimental | Over-the-counter dose of 2 x 440 mg capsules (880 mg, Capsicum Pepper Blend, Daily Manufacturing, Rockwell, North Carolina, USA) |
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| Placebo | Placebo Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary capsules | Dietary Supplement | Daily doses of dietary capsaicin or placebo in capsule form |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure and Vascular Stiffness | The investigators will assess peripheral and estimated central blood pressures and vascular stiffness using pulse wave analysis. | 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. | 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. | Baseline, 24 hours, and 6-weeks |
| Passive Leg Movement Hyperemia | The investigators will assess the hyperemic response to passive leg movement using ultrasound doppler. | 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 | Baseline, 24 hours, and 6-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Capsaicinoids | The investigators will collect urine to determine urinary capsaicin and associated metabolites to understand bioavailability and potential relation to function. | Baseline, 24 hours, and 6-weeks |
| Blood Lipids |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephen Ives, PhD | Contact | 5185808366 | sives@skidmore.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skidmore College | Recruiting | Saratoga Springs | New York | 12866 | United States |
Only deidentified data may be shared with the sponsor or research community through appropriate data repositories.
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Parallel: Participants are randomly assigned to one of two groups in parallel for the duration of the study
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The capsules will be placed into solid white color bottles, and labeled discreetly by a third party not directly involved with the research.
The investigators will collect blood to determine blood lipids (cholesterol) and glucose.
| Baseline and 6-weeks |