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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-08

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)

NCT00954902

Cardiovascular Psychological Stress

COMPLETED NA

Impact of Spices and Herbs on Endothelial Function

NCT01085019

Endothelial Function

COMPLETED NA

Nitric Oxide Mediated Vasodilatory Response to Hawthorn Standardized Extract

NCT01331486

Prehypertension Mild Hypertension

COMPLETED PHASE1

Wild Blueberries and Cardiovascular Health in Middle-aged/Older Men and Postmenopausal Women

NCT04530916

Hypertension Aging Endothelial Dysfunction +1 more

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Dietary Sodium, Oxidative Stress, and Pulsatile Hemodynamics

NCT04233957

Sodium Excess

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pre Hypertension Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel: Participants are randomly assigned to one of two groups in parallel for the duration of the study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The capsules will be placed into solid white color bottles, and labeled discreetly by a third party not directly involved with the research.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dietary Capsaicin

Over-the-counter dose of 2 x 440 mg capsules (880 mg, Capsicum Pepper Blend, Daily Manufacturing, Rockwell, North Carolina, USA)

Group Type EXPERIMENTAL

Dietary capsules

Intervention Type DIETARY_SUPPLEMENT

Daily doses of dietary capsaicin or placebo in capsule form

Placebo

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).

Group Type PLACEBO_COMPARATOR

Dietary capsules

Intervention Type DIETARY_SUPPLEMENT

Daily doses of dietary capsaicin or placebo in capsule form

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dietary capsules

Daily doses of dietary capsaicin or placebo in capsule form

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes