Back to resultsEffects of Antioxidants on Cardiovascular Risk Measures (Spice Study) (Spice)
Primary Purpose
Cardiovascular, Psychological Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Antioxidant Spice Blend
Trier Psychological Stressor
Placebo antioxidant concentrate
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular focused on measuring Spice, responses to stress, Inflammatory
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
Sites / Locations
- Penn State GCRC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Sham Comparator
Sham Comparator
Experimental
Experimental
Arm Label
No spice, no stress
No Spice, Stress
Spice, no stress
Spice and Stress
Arm Description
Subject are given placebo capsules and told they contain an antioxidant concentrate
Subjects are given placebo capsules and told they are receiving an equivalent amount of an antioxidant concentrate.
Outcomes
Primary Outcome Measures
IL-6 response to psychological stress at time points equal to and greater than 90 minutes post task
Secondary Outcome Measures
Serum/plasma changes in antioxidant activity and their relationship to inflammation outcomes
Endothelial function measured by endopat
Platelet function measured by PFA-100
Full Information
NCT ID
NCT00954902
First Posted
August 6, 2009
Last Updated
January 23, 2018
Sponsor
Penn State University
Collaborators
McCormick Science Institute
1. Study Identification
Unique Protocol Identification Number
NCT00954902
Brief Title
Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)
Acronym
Spice
Official Title
Development of a Dynamic Model of Inflammation for Studying the Anti-inflammatory Effects of Culinary Spices in Human Participants
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
McCormick Science Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular, Psychological Stress
Keywords
Spice, responses to stress, Inflammatory
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No spice, no stress
Arm Type
Sham Comparator
Arm Description
Subject are given placebo capsules and told they contain an antioxidant concentrate
Arm Title
No Spice, Stress
Arm Type
Sham Comparator
Arm Description
Subjects are given placebo capsules and told they are receiving an equivalent amount of an antioxidant concentrate.
Arm Title
Spice, no stress
Arm Type
Experimental
Arm Title
Spice and Stress
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
High Antioxidant Spice Blend
Intervention Description
14.5 g spice blend incorporated into a delivery meal including: cloves, cinnamon, oregano, rosemary, ginger, black pepper, paprika, garlic powder, and turmeric.
Intervention Type
Behavioral
Intervention Name(s)
Trier Psychological Stressor
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo antioxidant concentrate
Intervention Description
Placebo capsules
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Endothelial function measured by endopat
Time Frame
At baseline and 3.5 hours following the meal
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila G. West, PhD
Organizational Affiliation
Penn State
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann C. Skulas-Ray, B.S.
Organizational Affiliation
Penn State
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Penny M. Kris-Etherton, PhD, RD
Organizational Affiliation
Penn State
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State GCRC
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25592751
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)
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