Impact of Spices and Herbs on Endothelial Function
This study has been completed.
Sponsor:
Laval University
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
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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:
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 |
| 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
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
No publications provided by Laval University
Additional 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 March 03, 2015