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Trial record 6 of 10 for:    Oregano

Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study) (Spice)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00954902
Recruitment Status : Completed
First Posted : August 7, 2009
Last Update Posted : January 25, 2018
Sponsor:
Collaborator:
McCormick Science Institute
Information provided by (Responsible Party):
Sheila G West, Penn State University

Tracking Information
First Submitted Date  ICMJE August 6, 2009
First Posted Date  ICMJE August 7, 2009
Last Update Posted Date January 25, 2018
Study Start Date  ICMJE August 2009
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2009)
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 ]
Change History Complete list of historical versions of study NCT00954902 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
  • 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 ]
  • Endothelial function measured by endopat [ Time Frame: At baseline and 3.5 hours following the meal ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2009)
  • Serum/plasma changes in antioxidant activity and their relationship to inflammation outcomes [ Time Frame: assessed at 5 time points at each of 4 visits ]
  • Endothelial function measured by endopat [ Time Frame: pre and 4 hours post meal at each of four visits ]
  • Platelet function measured by PFA-100 [ Time Frame: pre and two post prandial time points at each of 4 visits ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)
Official Title  ICMJE Development of a Dynamic Model of Inflammation for Studying the Anti-inflammatory Effects of Culinary Spices in Human Participants
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular
  • Psychological Stress
Intervention  ICMJE
  • 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.
  • Other: Placebo antioxidant concentrate
    Placebo capsules
Study Arms  ICMJE
  • Sham Comparator: No spice, no stress
    Subject are given placebo capsules and told they contain an antioxidant concentrate
    Intervention: Other: Placebo antioxidant concentrate
  • Sham Comparator: No Spice, Stress
    Subjects are given placebo capsules and told they are receiving an equivalent amount of an antioxidant concentrate.
    Interventions:
    • Behavioral: Trier Psychological Stressor
    • Other: Placebo antioxidant concentrate
  • Experimental: Spice, no stress
    Intervention: Dietary Supplement: High Antioxidant Spice Blend
  • Experimental: Spice and Stress
    Interventions:
    • Dietary Supplement: High Antioxidant Spice Blend
    • Behavioral: Trier Psychological Stressor
Publications * McCrea CE, West SG, Kris-Etherton PM, Lambert JD, Gaugler TL, Teeter DL, Sauder KA, Gu Y, Glisan SL, Skulas-Ray AC. Effects of culinary spices and psychological stress on postprandial lipemia and lipase activity: results of a randomized crossover study and in vitro experiments. J Transl Med. 2015 Jan 16;13:7. doi: 10.1186/s12967-014-0360-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2011)
32
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2009)
50
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00954902
Other Study ID Numbers  ICMJE G264
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sheila G West, Penn State University
Study Sponsor  ICMJE Penn State University
Collaborators  ICMJE McCormick Science Institute
Investigators  ICMJE
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
PRS Account Penn State University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP