Impact of Spices and Herbs on Endothelial Function

Endothelial Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085019
• Other study ID #: INAF-2009-253
• Status: Completed
• Phase: N/A
• First received: March 9, 2010
• Last updated: June 26, 2012
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Endothelial Function

Intervention

Dietary Supplement:
• Cinnamon
2.8g/day of cinnamon in capsules during 4 weeks.
• Oregano
2.8g/day of oregano in capsules during 4 weeks.
• Ginger
2.8g/day of ginger in capsules during 4 weeks.
• Rosemary
2.8g/day of rosemary in capsules during 4 weeks.
• Black pepper
2.8g/day of black pepper in capsules for 4 weeks.
• Placebo
2.8 g/day of placebo in capsules (corn starch) during 4 weeks.

Locations

Country	Name	City	State
Canada	Institute of Nutraceuticals and Functional Foods	Quebec City	Quebec
Canada	Richardson Centre of Functional Foods and Nutracuticals	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	McCormick Canada Co

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function measured by endopat system (the endothelium-mediated changes in vacular tone)		at week 0 and week 4	No
Secondary	Circulating level of plasma lipoproteins-lipids		at week 0 and week 4	No
Secondary	Oxidative stress		at week 0 and week 4	No
Secondary	Endothelial activation and inflammatory markers		at week 0 and week 4	No