Psychological Stress Clinical Trial
— SpiceOfficial title:
Development of a Dynamic Model of Inflammation for Studying the Anti-inflammatory Effects of Culinary Spices in Human Participants
Verified date | January 2018 |
Source | Penn State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 32 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Penn State GCRC | University Park | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Penn State University | McCormick Science Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | Endothelial function measured by endopat | At baseline and 3.5 hours following the meal | ||
Secondary | 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 |
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