The Acute Effect of Spices on Vascular Health

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Oxidative Stress

Intervention / Treatment
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* Other: Herbs and spices
* Other: High fat meal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Consumption of a high fat meal (1000kcal, 45g fat) | Other: High fat meal<br>* Meal containing 1000kcal and 45g fat<br>|
| Experimental: Spice 2g<br>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. | Other: Herbs and spices<br>* Mix of commonly used herbs and spices<br>Other: High fat meal<br>* Meal containing 1000kcal and 45g fat<br>|
| Experimental: Spice 6g<br>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. | Other: Herbs and spices<br>* Mix of commonly used herbs and spices<br>Other: High fat meal<br>* Meal containing 1000kcal and 45g fat<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lipids, glucose regulation, Immune markers, Endothelium, Vascular