Impact of Spices and Herbs on Endothelial Function

June 26, 2012 updated by: Charles Couillard, Laval University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T 6C5
        • Richardson Centre of Functional Foods and Nutracuticals
    • Quebec
      • Quebec City, Quebec, Canada, G1V 0A6
        • Institute of Nutraceuticals and Functional Foods

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endothelial function measured by endopat system (the endothelium-mediated changes in vacular tone)
Time Frame: at week 0 and week 4
at week 0 and week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Circulating level of plasma lipoproteins-lipids
Time Frame: at week 0 and week 4
at week 0 and week 4
Oxidative stress
Time Frame: at week 0 and week 4
at week 0 and week 4
Endothelial activation and inflammatory markers
Time Frame: at week 0 and week 4
at week 0 and week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

McCormick Canada Co

Investigators

  • Principal Investigator: Charles Couillard, Ph.D, Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (ESTIMATE)

March 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 28, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INAF-2009-253

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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