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

NCT06363305 · Skidmore College

Recruiting

In plain English

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Official title

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

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.

Eligibility criteria

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.

Study design

Enrollment target: 80 participants

Allocation: randomized

Masking: triple

Age groups: adult, older_adult

Timeline

Starts: 2024-07-08

Estimated completion: 2025-12-31

Last updated: 2024-07-10

Interventions

Dietary Supplement: Dietary capsules

Primary outcomes

• Blood Pressure and Vascular Stiffness (Baseline, 24 hours, and 6-weeks)
• Heart Rate (HR) and HR variability (HRV) (Baseline, 24 hours, and 6-weeks)
• Flow Mediated Dilation (Baseline, 24 hours, and 6-weeks)

Sponsor

Skidmore College · other

With: American Heart Association

Contacts & investigators

ContactStephen Ives, PhD · contact · sives@skidmore.edu · 5185808366

All locations (1)

Skidmore CollegeRecruiting

Saratoga Springs, New York, United States

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