Clinical trial NCT00954902: Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)
Official title: Development of a Dynamic Model of Inflammation for Studying the Anti-inflammatory Effects of Culinary Spices in Human Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular
Psychological Stress
Keywords: Spice
responses to stress
Inflammatory
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: McCormick Science Institute
First posted: 2009-08-07
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: IL-6 response to psychological stress at time points equal to and greater than 90 minutes post task
timeFrame: At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal
Secondary outcomes:
measure: Serum/plasma changes in antioxidant activity and their relationship to inflammation outcomes
timeFrame: At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal
measure: Endothelial function measured by endopat
timeFrame: At baseline and 3.5 hours following the meal
measure: Platelet function measured by PFA-100
timeFrame: At baseline and specified intervals up to 2 hours following the stressor and 3.5 hours following the meal
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State GCRC
state: Pennsylvania
Study officials:
affiliation: Penn State
name: Sheila G. West, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State
name: Ann C. Skulas-Ray, B.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State
name: Penny M. Kris-Etherton, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCrea CE, West SG, Kris-Etherton PM, Lambert JD, Gaugler TL, Teeter DL, Sauder KA, Gu Y, Glisan SL, Skulas-Ray AC. Effects of culinary spices and psychological stress on postprandial lipemia and lipase activity: results of a randomized crossover study and in vitro experiments. J Transl Med. 2015 Jan 16;13:7. doi: 10.1186/s12967-014-0360-5.