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Impact of Spices and Herbs on Endothelial Function

This study has been completed.
Sponsor:
Collaborator:
McCormick Canada Co
Information provided by (Responsible Party):
Charles Couillard, Laval University
ClinicalTrials.gov Identifier:
NCT01085019
First received: March 9, 2010
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose
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 Intervention
Endothelial Function
 Dietary Supplement: Cinnamon
Dietary Supplement: Oregano
Dietary Supplement: Ginger
Dietary Supplement: Rosemary
Dietary Supplement: Black pepper
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:
  • Endothelial function measured by endopat system (the endothelium-mediated changes in vacular tone) [ Time Frame: at week 0 and week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Circulating level of plasma lipoproteins-lipids [ Time Frame: at week 0 and week 4 ] [ Designated as safety issue: No ]
  • Oxidative stress [ Time Frame: at week 0 and week 4 ] [ Designated as safety issue: No ]
  • Endothelial activation and inflammatory markers [ Time Frame: at week 0 and week 4 ] [ Designated as safety issue: No ]
Enrollment: 224
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:
The purpose is to assess whether the polyphenol/antioxidant content of different spices will affect endothelial function and other cardiovascular risk factors.
  Eligibility
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 
Study First Received: March 9, 2010
Last Updated: June 26, 2012
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 23, 2016