The Acute Effect of Spices on Vascular Health

Overview

The investigators aim to conduct a 3-period randomized controlled crossover study to investigate the postprandial effects of a high fat meal with spice on endothelial function, lipids/lipoproteins, immune function and plasma markers of antioxidants and oxidative stress. Metabolomic profiling will also be conducted. In random order, participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spice or a high fat meal containing 6g of spice. Between each treatment there will be a washout period of at least 3 days. It is hypothesized that consumption of a high fat meal with spice will attenuate postprandial endothelial impairment and triglyceride levels in a dose response manner compared with a high fat meal.

Full Title of Study: “The Postprandial Effects of a High Fat Meal Containing Spices on Endothelial Function: a Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 29, 2018

Detailed Description

A 3-period randomized controlled crossover study will be conducted to investigate the postprandial effects of a high fat meal with spices on endothelial function, lipids/lipoproteins, immune function, plasma antioxidants and markers of oxidative stress. Metabolomic profiling will also be conducted. In random order participants will consume either a high fat meal (1000kcal, 45g fat) or a high fat meal containing 2g of spices or a high fat meal containing 6g of spices with a 3 day washout period between each treatment. The following spices will be incorporated into the meal black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme. Endothelial function will be measured by flow mediated dilation of the brachial artery in the fasting state and 2 and 4 hours after the meal. Participants will also provide a fasting blood sample and samples will also be taken at 1, 2, 3 and 4 hours after the meal.

Interventions

  • Other: Herbs and spices
    • Mix of commonly used herbs and spices
  • Other: High fat meal
    • Meal containing 1000kcal and 45g fat

Arms, Groups and Cohorts

  • Active Comparator: Control
    • Consumption of a high fat meal (1000kcal, 45g fat)
  • Experimental: Spice 2g
    • Consumption of a high fat meal (1000kcal, 45g fat) with 2g of spice (mix of black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme) incorporated into the meal.
  • Experimental: Spice 6g
    • Consumption of a high fat meal (1000kcal, 45g fat) with 6g of spice (mix of black pepper, basil, bay leaf, cinnamon, coriander, cumin, ginger, oregano, parsley, rosemary, red pepper, turmeric and thyme) incorporated into the meal.

Clinical Trial Outcome Measures

Primary Measures

  • Change in endothelial function measured by flow mediated dilation (FMD) of the brachial artery
    • Time Frame: Change from baseline at 2 hours and 4 hours after meal consumption

Secondary Measures

  • Lipids and lipoproteins
    • Time Frame: Change from baseline during the 4 hours after meal consumption
  • Plasma Inflammatory cytokines
    • Time Frame: Change from baseline during the 4 hours after meal consumption
  • Inflammatory cytokines in isolated peripheral blood mononuclear cells
    • Time Frame: Change from baseline during the 4 hours after meal consumption
  • Glucose
    • Time Frame: Change from baseline during the 4 hours after meal consumption
  • Insulin
    • Time Frame: Change from baseline during the 4 hours after meal consumption
  • Plasma antioxidants (hydrophilic ORAC, lipophilic ORAC, total ORAC)
    • Time Frame: Change from baseline during the 4 hours after meal consumption
  • Oxidative stress
    • Time Frame: Change from baseline during the 4 hours after meal consumption
  • Plasma nitrite and nitrate
    • Time Frame: Change from baseline during the 4 hours after meal consumption
  • Plasma and Urine Metabolomic profiling
    • Time Frame: Change from baseline during the 4 hours after meal consumption

Participating in This Clinical Trial

Inclusion Criteria

  • male aged 40-65 years – BMI 25-35kg/m2 – nonsmoking – waist circumference =/> 94cm and at least one other CVD risk factor (elevated LDL-C (> 130 mg/dL), CRP (> 1 mg/L), elevated Triglycerides (≥ 150 mg/dL), reduced HDL-cholesterol (< 40 mg/dL), elevated blood pressure (systolic BP ≥ 130 or diastolic BP ≥ 85 mm Hg), elevated fasting glucose (≥ 100 mg/dL)) – low herb/spice consumers (consumption <1/day) Exclusion Criteria:

  • Chronic disease risk factors that are diagnostic of diabetes (fasting glucose > 126 mg/dL) or hypertension (SBP >160 mm Hg or DBP > 100 mm Hg). – Prescription of anti-hypertensive or glucose lowering drugs. – Established CVD, stroke, diabetes, liver, kidney or autoimmune disease – Use of cholesterol/lipid-lowering medication or supplements (psyllium, fish oil, soy lecithin, and phytoestrogens) and botanicals – weight loss of ≥10% of body weight within the 6 months prior to enrolling in the study – vegetarianism

Gender Eligibility: Male

Minimum Age: 40 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Penn State University
  • Collaborator
    • McCormick Science Institute
  • Provider of Information About this Clinical Study
    • Sponsor

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