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Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00954902
Acronym
Spice
Enrollment
32
Registered
2009-08-07
Start date
2009-08-31
Completion date
2010-09-30
Last updated
2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular, Psychological Stress

Keywords

Spice, responses to stress, Inflammatory

Brief 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.

Interventions

DIETARY_SUPPLEMENTHigh 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.

BEHAVIORALTrier 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.

OTHERPlacebo antioxidant concentrate

Placebo capsules

Sponsors

McCormick Science Institute
CollaboratorINDUSTRY
Penn State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
IL-6 response to psychological stress at time points equal to and greater than 90 minutes post taskAt baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal

Secondary

MeasureTime frame
Serum/plasma changes in antioxidant activity and their relationship to inflammation outcomesAt baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal
Endothelial function measured by endopatAt baseline and 3.5 hours following the meal
Platelet function measured by PFA-100At baseline and specified intervals up to 2 hours following the stressor and 3.5 hours following the meal

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026