The Effect of Spice Consumption on Postprandial Vascular Function

Study Overview
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Brief Summary
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A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. After each diet period a meal test will be conducted. Participants will consume a meal with a spice content corresponding to the diet period they have just completed. Endothelial function will be measured at 2 and 4 hours after meal consumption. Blood samples will also be taken during the 4 hours after meal consumption for measurement of lipids, immune and inflammatory markers.

Detailed Description
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A 3-period randomized cross-over, controlled feeding study will be conducted to determine the effect of chronic spice consumption on postprandial vascular function, lipid levels, immune and inflammatory markers. Participants will consume three test diets containing different amounts of spice. Each treatment period will last for 4 weeks. At baseline and after each diet period a postprandial test will be conducted. Flow mediated dilation (FMD) will conducted in the fasting state and a catheter will be inserted for blood sampling. Participants will consume a control test meal containing low spice at baseline and after each diet period the test meal will contain a level of spice that corresponds to the amount of spice consumed during the diet period. Blood samples will be taken at 30, 60, 120, 180 and 240 minutes after meal consumption, and FMD will be performed at 120 and 240 minutes.

Official Title
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The Effect of Chronic Consumption of Popular Spices on Postprandial Vascular Function

Conditions
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Cardiovascular Risk Factor

Intervention / Treatment
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* Other: Spice blend


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and postmenopausal women Overweight or obese (25-35kg/m2) Non-smoking Waist circumference >= 94cm for men and >=80cm for women At least one other of the following: LDL- cholesterol >130mg/dL CRP >1mg/L Triglycerides >=150mg/dL HDL <40mg/dL for men or <50mg/dL for women Systolic blood pressure >= 130mmHg or diastolic >= 85mmHg Fasting glucose >=100mg/dL Exclusion Criteria: Diabetes (fasting glucose >126mg/dL) Hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg) Prescribed anti-hypertensive or glucose lowering drugs Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease Use of cholesterol/lipid lowering medication or supplementation (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals Pregnancy or lactation 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: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

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
Interventional Model Description: 3 period randomized cross over
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Spice<br>The test meal ( 1200kcal and 44g fat) will contain  0.6g of spice blend | Other: Spice blend<br>* Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon<br>|
| Experimental: Moderate Spice<br>The test meal ( 1200kcal and 44g fat) will contain  3.7g of spice blend | Other: Spice blend<br>* Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon<br>|
| Experimental: Culinary Spice<br>The test meal ( 1200kcal and 44g fat) will contain  7.4g of spice blend | Other: Spice blend<br>* Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in flow mediated dilation | Endothelial function measured by FMD | Change from baseline at 2 hours and 4 hours after meal consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid and lipoproteins | Total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides | Change from baseline during the 4 hours after meal consumption | 
| Plasma Inflammatory cytokines | Serum: IL-1β, IL-6, IL-10, IL-12p70, interferon-gamma, monocyte chemoattractant protein-1, macrophage inflammatory protein-1alpha, TNF-alpha, vascular endothelial growth factor | Change from baseline during the 4 hours after meal consumption | 
| Inflammatory cytokines in isolated peripheral blood mononuclear cells | TNF-alpha, IL-6,NF-κB, I-κB, MAP kinase, COX-2, iNOS from stimulated and unstimulated lipopolysaccharides in peripheral blood mononuclear cells. Activation status of macrophages. | Change from baseline during the 4 hours after meal consumption | 
| Glucose | Plasma glucose | Change from baseline during the 4 hours after meal consumption | 
| Insulin | Plasma 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 |