Effects of Antioxidants on Cardiovascular Risk Measures (Spice Study)

NCT00954902 | Completed

• 1 other identifier: G264
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular; Psychological Stress

Keywords

Spice; responses to stress; Inflammatory

Outcome Measures

Primary Outcomes (1)

• IL-6 response to psychological stress at time points equal to and greater than 90 minutes post task

  At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal

Secondary Outcomes (3)

• Serum/plasma changes in antioxidant activity and their relationship to inflammation outcomes

  At baseline and intervals up to 2 hours following the stressor and 3.5 hours following the meal

• Endothelial function measured by endopat

  At baseline and 3.5 hours following the meal

• Platelet function measured by PFA-100

  At baseline and specified intervals up to 2 hours following the stressor and 3.5 hours following the meal

Study Arms (4)

No spice, no stress

SHAM COMPARATOR

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

Other: Placebo antioxidant concentrate

No Spice, Stress

SHAM COMPARATOR

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

Behavioral: Trier Psychological Stressor; Other: Placebo antioxidant concentrate

Spice, no stress

EXPERIMENTAL

Dietary Supplement: High Antioxidant Spice Blend

Spice and Stress

EXPERIMENTAL

Dietary Supplement: High Antioxidant Spice Blend; Behavioral: Trier Psychological Stressor

Interventions

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.

Spice and Stress; Spice, no stress

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.

No Spice, Stress; Spice and Stress

Placebo antioxidant concentrate OTHER

Placebo capsules

No Spice, Stress; No spice, no stress

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30-65
• BMI 25-40
• Non tobacco user
• Resting BP \< 160/100
• Fasting Glucose \< 126 mg/dL

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• McCormick Science Institute: collaborator

Study Sites (1)

Penn State GCRC

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

• 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.

  PMID: 25592751 DERIVED

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biobehavioral Health

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: August 7, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

US (1)