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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 24 hours, and 6-weeks
Summary
This trial aims to study the effects of dietary capsaicin on cardiovascular health, specifically looking at whether these effects differ between males and females. The researchers will be investigating how capsaicin impacts
Who is the study for?
This trial is for non-smoking men and women over 18 with high blood pressure, but otherwise healthy. It's not for those with heartburn, stomach issues, food allergies, trouble swallowing pills, or a severe sensitivity to spicy foods. People with serious illnesses or uncontrolled hypertension can't join. Women who are pregnant, trying to conceive, breastfeeding or without a period (not due to birth control) are also excluded.
What is being tested?
The study tests if dietary capsaicin affects cardiovascular health differently in men and women by looking at nitric oxide levels and markers like blood pressure and arterial stiffness. Participants will take dietary capsules containing capsaicin.
What are the potential side effects?
Potential side effects may include digestive discomfort such as heartburn or upset stomach due to the spicy nature of capsaicin. Since participants with excessive sensitivity to spice are excluded from the trial, severe reactions should be uncommon.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 24 hours, and 6-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 24 hours, and 6-weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood Pressure and Vascular Stiffness
Flow Mediated Dilation
Heart Rate (HR) and HR variability (HRV)
+2 moreSecondary study objectives
Blood Lipids
Urinary Capsaicinoids
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dietary CapsaicinExperimental Treatment1 Intervention
Over-the-counter dose of 2 x 440 mg capsules (880 mg, Capsicum Pepper Blend, Daily Manufacturing, Rockwell, North Carolina, USA)
Group II: PlaceboPlacebo Group1 Intervention
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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Who is running the clinical trial?
Skidmore CollegeLead Sponsor
19 Previous Clinical Trials
1,032 Total Patients Enrolled
American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,412 Total Patients Enrolled
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