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Impact of Spices and Herbs on Endothelial Function

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ClinicalTrials.gov Identifier: NCT01085019
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : June 28, 2012
Sponsor:
Collaborator:
McCormick Canada Co
Information provided by (Responsible Party):
Charles Couillard, Laval University

Study Description
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Brief Summary:
The general objective of the study is to investigate the effects of the daily consumption of spices and herbs for four (4) consecutive weeks in endothelial function and cardiovascular risk factors of men and postmenopausal women.

Condition or disease Intervention/treatment Phase
Endothelial Function Dietary Supplement: Cinnamon Dietary Supplement: Oregano Dietary Supplement: Ginger Dietary Supplement: Rosemary Dietary Supplement: Black pepper Dietary Supplement: Placebo Not Applicable

Detailed Description:
The purpose is to assess whether the polyphenol/antioxidant content of different spices will affect endothelial function and other cardiovascular risk factors.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Investigation of the Impact of Spices and Herbs on Endothelial Function and Other CVD Risk Factors in Men and Women.
Study Start Date : March 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : December 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: Dietary supplement: Cinnamon Dietary Supplement: Cinnamon
2.8g/day of cinnamon in capsules during 4 weeks.
Experimental: Dietary supplement: Oregano Dietary Supplement: Oregano
2.8g/day of oregano in capsules during 4 weeks.
Experimental: Dietary supplement: Ginger Dietary Supplement: Ginger
2.8g/day of ginger in capsules during 4 weeks.
Experimental: Dietary supplement: Rosemary Dietary Supplement: Rosemary
2.8g/day of rosemary in capsules during 4 weeks.
Experimental: Dietary supplement: Black pepper Dietary Supplement: Black pepper
2.8g/day of black pepper in capsules for 4 weeks.
Placebo Comparator: Dietary supplement: Placebo Dietary Supplement: Placebo
2.8 g/day of placebo in capsules (corn starch) during 4 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Endothelial function measured by endopat system (the endothelium-mediated changes in vacular tone) [ Time Frame: at week 0 and week 4 ]

Secondary Outcome Measures :
  1. Circulating level of plasma lipoproteins-lipids [ Time Frame: at week 0 and week 4 ]
  2. Oxidative stress [ Time Frame: at week 0 and week 4 ]
  3. Endothelial activation and inflammatory markers [ Time Frame: at week 0 and week 4 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 40-70 yrs
  • Men and postmenopausal women
  • Waist girth >102cm (men) or >88cm (women)
  • LDL-C > 2.8 mmol/L
  • Framingham 10‐yr risk score < 10%
  • Marginal endothelial dysfunction
  • Non smoker

Exclusion Criteria:

  • Medication for lipid, hypertension, diabetes
  • History of CVD, diabetes, other endocrines disorders
  • Pre‐menopausal women
  • Alcohol consumption > 1 drink per day
  • Unusual dietary habits (e.g. vegetarism)
  • Chronic use of supplements (estrogens, vitamins, minerals or flavonoids)
  • Aversion or intolerance for spices and/or herbs
  • Injury to fingers or amrs that would interfere with endothelial function measurement
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085019


Locations
Canada, Manitoba
Richardson Centre of Functional Foods and Nutracuticals
Winnipeg, Manitoba, Canada, R3T 6C5
Canada, Quebec
Institute of Nutraceuticals and Functional Foods
Quebec City, Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
McCormick Canada Co
Investigators
Principal Investigator: Charles Couillard, Ph.D Laval University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Charles Couillard, Professor, Laval University
ClinicalTrials.gov Identifier: NCT01085019     History of Changes
Other Study ID Numbers: INAF-2009-253
First Posted: March 11, 2010    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012

Keywords provided by Charles Couillard, Laval University:
Endothelial function
Cardiovascular risk factors
Spices
Herbs
Antioxidant