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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

March 9, 2010
June 26, 2012
March 2010
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01085019 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Impact of Spices and Herbs on Endothelial Function
Investigation of the Impact of Spices and Herbs on Endothelial Function and Other CVD Risk Factors in Men and Women.

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.

The purpose is to assess whether the polyphenol/antioxidant content of different spices will affect endothelial function and other cardiovascular risk factors.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Endothelial Function
  • Dietary Supplement: Cinnamon
    2.8g/day of cinnamon in capsules during 4 weeks.
  • Dietary Supplement: Oregano
    2.8g/day of oregano in capsules during 4 weeks.
  • Dietary Supplement: Ginger
    2.8g/day of ginger in capsules during 4 weeks.
  • Dietary Supplement: Rosemary
    2.8g/day of rosemary in capsules during 4 weeks.
  • Dietary Supplement: Black pepper
    2.8g/day of black pepper in capsules for 4 weeks.
  • Dietary Supplement: Placebo
    2.8 g/day of placebo in capsules (corn starch) during 4 weeks.
  • Experimental: Dietary supplement: Cinnamon
    Intervention: Dietary Supplement: Cinnamon
  • Experimental: Dietary supplement: Oregano
    Intervention: Dietary Supplement: Oregano
  • Experimental: Dietary supplement: Ginger
    Intervention: Dietary Supplement: Ginger
  • Experimental: Dietary supplement: Rosemary
    Intervention: Dietary Supplement: Rosemary
  • Experimental: Dietary supplement: Black pepper
    Intervention: Dietary Supplement: Black pepper
  • Placebo Comparator: Dietary supplement: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
224
December 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01085019
INAF-2009-253
No
Charles Couillard, Laval University
Laval University
McCormick Canada Co
Principal Investigator: Charles Couillard, Ph.D Laval University
Laval University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP