Impact of Spices and Herbs on Endothelial Function

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	40 Years to 70 Years (Adult, Senior)
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Carnovale V, Paradis ME, Gigleux I, Ramprasath VR, Couture P, Jones PJ, Lamarche B, Couillard C. Correlates of reactive hyperemic index in men and postmenopausal women. Vasc Med. 2013 Dec;18(6):340-6. doi: 10.1177/1358863X13507975.

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
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