Impact of Sex in the Effect of Dietary Capsaicin on Cardiovascular Health

Phase

N/A

Condition

Williams Syndrome

Stress

Vascular Diseases

Treatment

Dietary capsules

Clinical Study ID

NCT06363305

2402-1139

Ages > 18
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

relatively healthy (other than elevated blood pressure) non-smoking men and womenover the age of 18 from the local community

Exclusion

Exclusion Criteria:

Women who are without a period (not due to a birth control method, intrauterinedevice or menopause), are pregnant, attempting to conceive, or are breastfeedingwill be excluded.
uncontrolled hypertension
Anyone with severe illness or compromised or suppressed immune system (e.g. takingimmune 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 ulcerdisease may be excluded.

Study Design

Dietary capsules

July 08, 2024

December 31, 2025

Study 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.

Connect with a study center

Skidmore College
Saratoga Springs, New York 12866
United States
Active - Recruiting

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