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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00954902
Other study ID # G264
Secondary ID
Status Completed
Phase N/A
First received August 6, 2009
Last updated January 23, 2018
Start date August 2009
Est. completion date September 2010

Study information

Verified date January 2018
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

Country Name City State
United States Penn State GCRC University Park Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Penn State University McCormick Science Institute

Country where clinical trial is conducted

United States, 

Outcome

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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