Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Cardiovascular Psychological Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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No spice, no stress

Subject are given placebo capsules and told they contain an antioxidant concentrate

Group Type SHAM_COMPARATOR

Placebo antioxidant concentrate

Intervention Type OTHER

Placebo capsules

No Spice, Stress

Subjects are given placebo capsules and told they are receiving an equivalent amount of an antioxidant concentrate.

Group Type SHAM_COMPARATOR

Trier Psychological Stressor

Intervention Type 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

Intervention Type OTHER

Placebo capsules

Spice, no stress

Group Type EXPERIMENTAL

High Antioxidant Spice Blend

Intervention Type 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.

Spice and Stress

Group Type EXPERIMENTAL

High Antioxidant Spice Blend

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type BEHAVIORAL

Placebo antioxidant concentrate

Placebo capsules

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes