Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study) (Spice)

January 23, 2018 updated by: Sheila G West, Penn State University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Penn State GCRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: No spice, no stress
Subject are given placebo capsules and told they contain an antioxidant concentrate
Other: Placebo antioxidant concentrate
Placebo capsules
Sham Comparator: No Spice, Stress
Subjects are given placebo capsules and told they are receiving an equivalent amount of an antioxidant concentrate.
Other: Placebo antioxidant concentrate
Placebo capsules
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.
Experimental: Spice, no stress
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.
Experimental: Spice and Stress
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal

Secondary Outcome Measures

Outcome Measure
Time Frame
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
At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal
Endothelial function measured by endopat
Time Frame: At baseline and 3.5 hours following the meal
At baseline and 3.5 hours following the meal
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
At baseline and specified intervals up to 2 hours following the stressor and 3.5 hours following the meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

McCormick Science Institute

Investigators

  • Principal Investigator: Sheila G. West, PhD, Penn State
  • Principal Investigator: Ann C. Skulas-Ray, B.S., Penn State
  • Principal Investigator: Penny M. Kris-Etherton, PhD, RD, Penn State

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

August 6, 2009

First Submitted That Met QC Criteria

August 6, 2009

First Posted (Estimate)

August 7, 2009

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G264

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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