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NCT Number: NCT06363305

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skidmore College

Saratoga Springs, New York, 12866, United States

Location status: Recruiting

Location contact

Stephen Ives, Ph.D.

CONTACT

[email protected]

518-580-8366

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary capsules

Dietary Supplement

Daily doses of dietary capsaicin or placebo in capsule form

Primary outcomes

  1. Blood Pressure and Vascular Stiffness

    Time frame: Baseline, 24 hours, and 6-weeks

    The investigators will assess peripheral and estimated central blood pressures and vascular stiffness using pulse wave analysis.

  2. Heart Rate (HR) and HR variability (HRV)

    Time frame: Baseline, 24 hours, and 6-weeks

    The investigators will assess HR and HRV using electrocardiogram and standard techniques to determine time and frequency domain estimates of HRV.

  3. Flow Mediated Dilation

    Time frame: Baseline, 24 hours, and 6-weeks

    The investigators will assess brachial artery flow-mediated dilation using ischemia-reperfusion and ultrasound doppler to assess the dilatory capacity and reactive hyperemia.

  4. Passive Leg Movement Hyperemia

    Time frame: Baseline, 24 hours, and 6-weeks

    The investigators will assess the hyperemic response to passive leg movement using ultrasound doppler.

  5. Near Infrared Spectroscopy (NIRS) Vascular Occlusion Test

    Time frame: Baseline, 24 hours, and 6-weeks

    The investigators will assess the metabolic capacity and vascular reactivity using ischemia-reperfusion and NIRS

Secondary outcomes

  1. Urinary Capsaicinoids

    Time frame: Baseline, 24 hours, and 6-weeks

    The investigators will collect urine to determine urinary capsaicin and associated metabolites to understand bioavailability and potential relation to function.

  2. Blood Lipids

    Time frame: Baseline and 6-weeks

    The investigators will collect blood to determine blood lipids (cholesterol) and glucose.

Study contacts

Contact information is provided by the study sponsor or research team.

Stephen Ives, PhD

CONTACT

[email protected]

5185808366

Sponsors and collaborators

Lead sponsor

Skidmore College

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 12, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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