Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether feeding highly antioxidant spices of providing these same antioxidants as capsules is able to affect cardiovascular risk measures. Because this is a new area of research, the investigators will use many measures to assess this question including blood markers, tests of blood vessel health, measures of blood pressure responses, measures of clotting activity, and other inflammation measures.

Official Title
-----------------
Development of a Dynamic Model of Inflammation for Studying the Anti-inflammatory Effects of Culinary Spices in Human Participants

Conditions
-----------------
Cardiovascular, Psychological Stress

Intervention / Treatment
-----------------
* Dietary Supplement: High Antioxidant Spice Blend
* Behavioral: Trier Psychological Stressor
* Other: Placebo antioxidant concentrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 30-65 BMI 25-40 Non tobacco user Resting BP < 160/100 Fasting Glucose < 126 mg/dL Exclusion Criteria: Tobacco use Use of female hormones Breastfeeding or planning to become pregnant during the study Use of lipid-lowering or blood pressure medications Chronic Inflammatory Disease or osteoarthritis requiring regular use of medication Chronic use of any form of anti-inflammatory or anti-psychotic drugs Use of daily aspirin or supplements (except stable dose of calcium) History of heart attack or stroke, renal or hepatic disease, implanted medical devices, gastrointestinal disease Allergy or intolerance to any study foods Injury to fingers or arms that would interfere with vascular and blood pressure measurements Inability to comply with study protocol Allergy to adhesives or latex Aerobic exercise exceeding 2 hours per week

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: No spice, no stress<br>Subject are given placebo capsules and told they contain an antioxidant concentrate | Other: Placebo antioxidant concentrate<br>* Placebo capsules<br>|
| Sham Comparator: No Spice, Stress<br>Subjects are given placebo capsules and told they are receiving an equivalent amount of an antioxidant concentrate. | Behavioral: Trier Psychological Stressor<br>* This is a psychological stressor that is used to invoked stress responses in human subjects. Subjects are told they are taped and evaluated and deliver the speech in front of a trained panel of judges.<br>Other: Placebo antioxidant concentrate<br>* Placebo capsules<br>|
| Experimental: Spice, no stress<br> | Dietary Supplement: High Antioxidant Spice Blend<br>* 14.5 g spice blend incorporated into a delivery meal including: cloves, cinnamon, oregano, rosemary, ginger, black pepper, paprika, garlic powder, and turmeric.<br>|
| Experimental: Spice and Stress<br> | Dietary Supplement: High Antioxidant Spice Blend<br>* 14.5 g spice blend incorporated into a delivery meal including: cloves, cinnamon, oregano, rosemary, ginger, black pepper, paprika, garlic powder, and turmeric.<br>Behavioral: Trier Psychological Stressor<br>* This is a psychological stressor that is used to invoked stress responses in human subjects. Subjects are told they are taped and evaluated and deliver the speech in front of a trained panel of judges.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-6 response to psychological stress at time points equal to and greater than 90 minutes post task |  | At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum/plasma changes in antioxidant activity and their relationship to inflammation outcomes |  | At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal | 
| Endothelial function measured by endopat |  | At baseline and 3.5 hours following the meal | 
| Platelet function measured by PFA-100 |  | At baseline and specified intervals up to 2 hours following the stressor and 3.5 hours following the meal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spice, responses to stress, Inflammatory