Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)

Not Applicable

Completed

• Conditions: Psychological Stress; Cardiovascular
• Interventions: Other: Placebo antioxidant concentrate; Dietary Supplement: High Antioxidant Spice Blend; Behavioral: Trier Psychological Stressor

• Registration Number: NCT00954902
• Lead Sponsor: Penn State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-06
• Study First Submitted QC: 2009-08-06
• Study First Posted: 2009-08-07
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No spice, no stress	Placebo antioxidant concentrate	Subject are given placebo capsules and told they contain an antioxidant concentrate
No Spice, Stress	Placebo antioxidant concentrate	Subjects are given placebo capsules and told they are receiving an equivalent amount of an antioxidant concentrate.
Spice and Stress	Trier Psychological Stressor	-
Spice, no stress	High Antioxidant Spice Blend	-
No Spice, Stress	Trier Psychological Stressor	Subjects are given placebo capsules and told they are receiving an equivalent amount of an antioxidant concentrate.
Spice and Stress	High Antioxidant Spice Blend	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Penn State GCRC; 🇺🇸 University Park, Pennsylvania, United States