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

Hypertension Clinical Trial

Official title:

Impact of Sex in the Effect of Dietary Capsaicin on Cardiovascular Health: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06363305
• Other study ID #: 2402-1139
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Skidmore College
• Contact: Stephen Ives, PhD
• Phone: 5185808366
• Email: sives[@]skidmore.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

• 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 ulcer disease may be excluded.

Related Conditions & MeSH terms

• Hypertension
• Pre Hypertension
• Prehypertension

Intervention

Dietary Supplement:
• Dietary capsules
Daily doses of dietary capsaicin or placebo in capsule form

Locations

Country	Name	City	State
United States	Skidmore College	Saratoga Springs	New York

Sponsors (2)

Lead Sponsor	Collaborator
Skidmore College	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Passive Leg Movement Hyperemia	The investigators will assess the hyperemic response to passive leg movement using ultrasound doppler.	Baseline, 24 hours, and 6-weeks
Primary	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
Secondary	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
Secondary	Blood Lipids	The investigators will collect blood to determine blood lipids (cholesterol) and glucose.	Baseline and 6-weeks