NCT01085019

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

1.3 years

First QC Date

March 9, 2010

Last Update Submit

June 26, 2012

Conditions

Endothelial Function

Keywords

Endothelial functionCardiovascular risk factorsSpicesHerbsAntioxidant

Outcome Measures

Primary Outcomes (1)

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

    at week 0 and week 4

Secondary Outcomes (3)

  • 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

Study Arms (6)

Dietary supplement: Cinnamon

EXPERIMENTAL
Dietary Supplement: Cinnamon

Dietary supplement: Oregano

EXPERIMENTAL
Dietary Supplement: Oregano

Dietary supplement: Ginger

EXPERIMENTAL
Dietary Supplement: Ginger

Dietary supplement: Rosemary

EXPERIMENTAL
Dietary Supplement: Rosemary

Dietary supplement: Black pepper

EXPERIMENTAL
Dietary Supplement: Black pepper

Dietary supplement: Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

CinnamonDIETARY_SUPPLEMENT

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

Dietary supplement: Cinnamon
OreganoDIETARY_SUPPLEMENT

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

Dietary supplement: Oregano
GingerDIETARY_SUPPLEMENT

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

Dietary supplement: Ginger
RosemaryDIETARY_SUPPLEMENT

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

Dietary supplement: Rosemary
Black pepperDIETARY_SUPPLEMENT

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

Dietary supplement: Black pepper
PlaceboDIETARY_SUPPLEMENT

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

Dietary supplement: Placebo

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Richardson Centre of Functional Foods and Nutracuticals

Winnipeg, Manitoba, R3T 6C5, Canada

Location

Institute of Nutraceuticals and Functional Foods

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (1)

  • Carnovale V, Paradis ME, Gigleux I, Ramprasath VR, Couture P, Jones PJ, Lamarche B, Couillard C. Correlates of reactive hyperemic index in men and postmenopausal women. Vasc Med. 2013 Dec;18(6):340-6. doi: 10.1177/1358863X13507975.

    PMID: 24292639DERIVED

MeSH Terms

Interventions

ginger extractblack pepper oil

Study Officials

  • Charles Couillard, Ph.D

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 9, 2010

First Posted

March 11, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2011

Study Completion

December 1, 2011

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations

CA(2)