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Completed

NCT Number: NCT01085019

Impact of Spices and Herbs on Endothelial Function

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.

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Key information

Conditions

Endothelial Function

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richardson Centre of Functional Foods and Nutracuticals, Winnipeg, Manitoba, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cinnamon

Dietary Supplement

2.8g/day of cinnamon in capsules during 4 weeks.

Oregano

Dietary Supplement

2.8g/day of oregano in capsules during 4 weeks.

Ginger

Dietary Supplement

2.8g/day of ginger in capsules during 4 weeks.

Rosemary

Dietary Supplement

2.8g/day of rosemary in capsules during 4 weeks.

Black pepper

Dietary Supplement

2.8g/day of black pepper in capsules for 4 weeks.

Placebo

Dietary Supplement

2.8 g/day of placebo in capsules (corn starch) during 4 weeks.

Primary outcomes

  1. Endothelial function measured by endopat system (the endothelium-mediated changes in vacular tone)

    Time frame: at week 0 and week 4

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • McCormick Canada Co

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 11, 2010
Registry last updated
Jun 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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