Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study) - Full Text View

Sponsors and Collaborators:	Penn State University McCormick Science Institute
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00954902

Purpose

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, we 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.

Condition	Intervention
Inflammatory and Cardiovascular Responses to Psychological Stress	Dietary Supplement: High Antioxidant Spice Blend Behavioral: Trier Psychological Stressor

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Crossover Assignment, Efficacy Study
Official Title:	Development of a Dynamic Model of Inflammation for Studying the Anti-inflammatory Effects of Culinary Spices in Human Participants

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants Stress

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:

IL-6 response to psychological stress at time points equal to and greater than 90 minutes post task [ Time Frame: 90 and 120 minutes post stressor ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum/plasma changes in antioxidant activity and their relationship to inflammation outcomes [ Time Frame: assessed at 5 time points at each of 4 visits ] [ Designated as safety issue: No ]
Endothelial function measured by endopat [ Time Frame: pre and 4 hours post meal at each of four visits ] [ Designated as safety issue: No ]
Platelet function measured by PFA-100 [ Time Frame: pre and two post prandial time points at each of 4 visits ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	August 2009

Arms	Assigned Interventions
No spice, no stress: No Intervention control visit
No Spice, Stress: Sham Comparator Subjects are given placebo capsules and told they are receiving an equivalent amount of an antioxidant concentrate.	Behavioral: Trier Psychological Stressor This is a pyschological 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.
Spice, no stress: Experimental	Dietary Supplement: High Antioxidant Spice Blend 14.5 g spice blend incorporated into a delivery meal including: cloves, cinnamon, oregano, rosemary, ginger, black pepper, paprika, garlic powder, and turmeric.
Spice and Stress: Experimental	Dietary Supplement: High Antioxidant Spice Blend 14.5 g spice blend incorporated into a delivery meal including: cloves, cinnamon, oregano, rosemary, ginger, black pepper, paprika, garlic powder, and turmeric. Behavioral: Trier Psychological Stressor This is a pyschological 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.

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954902

Contacts

Contact: Ann Skulas-Ray, B.S.

814-867-1822

ann.skulas@gmail.com

Locations

United States, Pennsylvania
Penn State GCRC	Recruiting
University Park, Pennsylvania, United States, 16802

Sponsors and Collaborators

Penn State University

McCormick Science Institute

Investigators

Principal Investigator:	Sheila G. West, PhD	Penn State
Principal Investigator:	Ann C. Skulas-Ray, B.S.	Penn State
Principal Investigator:	Penny M. Kris-Etherton, PhD, RD	Penn State

More Information

No publications provided

Responsible Party:	Penn State University ( Sheila West, Associate Professor )
Study ID Numbers:	G264
Study First Received:	August 6, 2009
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00954902 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Penn State University:

Spice
Psychological Stress
Cardiovascular

Study placed in the following topic categories:

Cinnamon
Turmeric
Turmeric extract
Antioxidants
Stress, Psychological
Stress

Ginger
Cayenne
Garlic
Behavioral Symptoms
Inflammation

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Stress, Psychological

Protective Agents
Pharmacologic Actions
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 11, 2009