Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)

Psychological Stress Clinical Trial

— Spice  

Official title:

Development of a Dynamic Model of Inflammation for Studying the Anti-inflammatory Effects of Culinary Spices in Human Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00954902
• Other study ID #: G264
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular
• Psychological Stress
• Stress, Psychological

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