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

Skidmore College

Status: Enrolling

Conditions: Hypertension; Pre Hypertension

Treatments: Dietary Supplement: Dietary capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT06363305

2402-1139

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Dietary Capsaicin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Dietary capsules

Placebo

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Dietary capsules