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

NCT06363305 | Recruiting

• 1 other identifier: 2402-1139
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre Hypertension; Hypertension

Keywords

vascular stiffness; blood pressure; vascular function

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• Passive Leg Movement Hyperemia

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

  Baseline, 24 hours, and 6-weeks

• 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 Outcomes (2)

• Urinary Capsaicinoids

  Baseline, 24 hours, and 6-weeks

• Blood Lipids

  Baseline and 6-weeks

Study Arms (2)

Dietary Capsaicin

EXPERIMENTAL

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

Dietary Supplement: Dietary capsules

Placebo

PLACEBO COMPARATOR

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).

Dietary Supplement: Dietary capsules

Interventions

Dietary capsules DIETARY_SUPPLEMENT

Daily doses of dietary capsaicin or placebo in capsule form

Dietary Capsaicin; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Skidmore College: lead
• American Heart Association: collaborator

Study Sites (1)

Skidmore College

Saratoga Springs, New York, 12866, United States

RECRUITING

MeSH Terms

Conditions

Prehypertension; Hypertension

Interventions

Diet

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Stephen Ives, PhD

CONTACT

5185808366; sives@skidmore.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The capsules will be placed into solid white color bottles, and labeled discreetly by a third party not directly involved with the research.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: July 8, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)