Impact of Spices and Herbs on Endothelial Function

Study Overview
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Brief Summary
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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.

Detailed Description
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The purpose is to assess whether the polyphenol/antioxidant content of different spices will affect endothelial function and other cardiovascular risk factors.

Official Title
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Investigation of the Impact of Spices and Herbs on Endothelial Function and Other CVD Risk Factors in Men and Women.

Conditions
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Endothelial Function

Intervention / Treatment
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* Dietary Supplement: Cinnamon
* Dietary Supplement: Oregano
* Dietary Supplement: Ginger
* Dietary Supplement: Rosemary
* Dietary Supplement: Black pepper
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary supplement: Cinnamon<br> | Dietary Supplement: Cinnamon<br>* 2.8g/day of cinnamon in capsules during 4 weeks.<br>|
| Experimental: Dietary supplement: Oregano<br> | Dietary Supplement: Oregano<br>* 2.8g/day of oregano in capsules during 4 weeks.<br>|
| Experimental: Dietary supplement: Ginger<br> | Dietary Supplement: Ginger<br>* 2.8g/day of ginger in capsules during 4 weeks.<br>|
| Experimental: Dietary supplement: Rosemary<br> | Dietary Supplement: Rosemary<br>* 2.8g/day of rosemary in capsules during 4 weeks.<br>|
| Experimental: Dietary supplement: Black pepper<br> | Dietary Supplement: Black pepper<br>* 2.8g/day of black pepper in capsules for 4 weeks.<br>|
| Placebo Comparator: Dietary supplement: Placebo<br> | Dietary Supplement: Placebo<br>* 2.8 g/day of placebo in capsules (corn starch) during 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endothelial function, Cardiovascular risk factors, Spices, Herbs, Antioxidant