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Completed

NCT Number: NCT00954902

Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)

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.

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Key information

Conditions

Cardiovascular Behavior Behavioral Symptoms Psychological Stress Stress, Psychological

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State GCRC

University Park, Pennsylvania, 16802, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Antioxidant Spice Blend

Dietary Supplement

14.5 g spice blend incorporated into a delivery meal including: cloves, cinnamon, oregano, rosemary, ginger, black pepper, paprika, garlic powder, and turmeric.

Trier Psychological Stressor

Behavioral

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.

Placebo antioxidant concentrate

Other

Placebo capsules

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Endothelial function measured by endopat

    Time frame: At baseline and 3.5 hours following the meal

  3. 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

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • McCormick Science Institute

Registry information

Official study title

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

Acronym: Spice

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 7, 2009
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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