Effect of a Spice Blend on Cardiovascular Risk Factors and Diet Satisfaction

Study Overview
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Brief Summary
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This study is a randomized 3-period crossover, controlled feeding study designed to evaluate the effects of the most commonly consumed spices in the U.S. on CVD risk factors, inflammation & immune function, and diet satisfaction in participants at risk for CVD.

Detailed Description
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A 3-period randomized crossover controlled-feeding study will be conducted. Participants will be randomly assigned to receive each 4-week treatment (diet) in random order. Each test diet period will be separated by a standard 4-week compliance break. Data collection will be conducted across at baseline (start of study) and the end of each diet period to assess the effects of chronic spice consumption on selected cardiovascular endpoints.

Official Title
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The Effect of Chronic Consumption of Popular Spices on Risk Factors for Cardiovascular Disease (CVD), Inflammation & Immune Function, and Diet Satisfaction

Conditions
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Cardiovascular Disease, Inflammation

Intervention / Treatment
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* Other: Controlled feeding diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: overweight or obese (25-35kg/m2) non-smoking male or female 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SD-Low<br>Average American Diet (32% of calories from fat, 11% of calories from saturated fat and 3400mg sodium/day) with a minimal amount of spices (<1g/day for all diets). Post prandial test meal will be contain minimal amounts of spice. | Other: Controlled feeding diet<br>* Average American diet with different levels of spices<br>|
| Experimental: SD-Mod<br>Average American Diet (32% of calories from fat, 11% of calories from saturated fat and 3400mg sodium/day) with a moderate amount of spices ( 3g/day in the 2100kcal diet). Post prandial test meal will be contain a moderate amount of spice. | Other: Controlled feeding diet<br>* Average American diet with different levels of spices<br>|
| Experimental: SD-Culinary<br>Average American Diet (32% of calories from fat, 11% of calories from saturated fat and 3400mg sodium/day) with a culinary dose of spices (6g/day in the 2100kcal diet). Post prandial test meal will be contain a culinary amount of spice. | Other: Controlled feeding diet<br>* Average American diet with different levels of spices<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lipid/lipoprotein profile | Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides | Change from baseline in lipid/lipoprotein profile at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central blood pressure |  | Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | 
| Brachial blood pressure |  | Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | 
| Augmentation index |  | Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | 
| Pulse wave velocity |  | Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | 
| HDL function |  | Change from baseline in lipid/lipoprotein profile at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | 
| Change in Glucose |  | Change from baseline in glucose at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | 
| Change in Insulin |  | Change from baseline in insulin at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | 
| Diet satisfaction | Questionnaire | After each 4 week diet period | 
| Change in flow mediated dilation | Only to be completed on men and postmenopausal women | Change from baseline in flow mediated dilation at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | 
| Inflammation and immune fuction | 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 at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | 
| Ambulatory blood pressure |  | Change from baseline at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | 
| in vitro production of inflammatory cytokines and immune markers | effect of spice on in vitro production of 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 at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) | 
| Change in lipoprotein particle size and subclasses | LDL, LDLR [i.e., LDL-(IDL + Lp(a))], Lp(a), IDL, HDL, HDL2, HDL3, VLDL, VLDL1+2, VLDL3, TC, TG, Non HDL, Remnant Lipoproteins, LDL4, LDL3, LDL2, ApoB100, ApoA1, ApoB100:A1. | Change lipoprotein particle size and subclasses at the end of diet period 1 (week 4), diet period 2 (week 10), diet period (week 16) |