Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)

This study has been completed.
Sponsor:
Collaborator:
McCormick Science Institute
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00954902
First received: August 6, 2009
Last updated: August 16, 2011
Last verified: May 2011
  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, 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.


Condition Intervention
Cardiovascular
Psychological Stress
Dietary Supplement: High Antioxidant Spice Blend
Behavioral: Trier Psychological Stressor
Other: Placebo antioxidant concentrate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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:


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: At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum/plasma changes in antioxidant activity and their relationship to inflammation outcomes [ Time Frame: At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal ] [ Designated as safety issue: No ]
  • Endothelial function measured by endopat [ Time Frame: At baseline and 3.5 hours following the meal ] [ Designated as safety issue: No ]
  • Platelet function measured by PFA-100 [ Time Frame: At baseline and specified intervals up to 2 hours following the stressor and 3.5 hours following the meal ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: August 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: No spice, no stress
Subject are given placebo capsules and told they contain an antioxidant concentrate
Other: Placebo antioxidant concentrate
Placebo capsules
Sham Comparator: No Spice, Stress
Subjects are given placebo capsules and told they are receiving an equivalent amount of an antioxidant concentrate.
Behavioral: Trier Psychological Stressor
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.
Other: Placebo antioxidant concentrate
Placebo capsules
Experimental: Spice, no stress 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.
Experimental: Spice and Stress 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 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
Penn State GCRC
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: Sheila West, Associate Professor, Penn State University
ClinicalTrials.gov Identifier: NCT00954902     History of Changes
Other Study ID Numbers: G264
Study First Received: August 6, 2009
Last Updated: August 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Spice
responses to stress
Inflammatory

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014