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Effects of Purple Vegetables on Cardiovascular Disease (CVD) Risk Factors

This study is currently recruiting participants.
Verified October 2016 by Kelly Anne Meckling, PhD, University of Guelph
Sponsor:
ClinicalTrials.gov Identifier:
NCT01564498
First Posted: March 27, 2012
Last Update Posted: October 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ontario Ministry of Agriculture, Food and Rural Affairs
Information provided by (Responsible Party):
Kelly Anne Meckling, PhD, University of Guelph
March 22, 2012
March 27, 2012
October 26, 2016
April 2012
December 2017   (Final data collection date for primary outcome measure)
Blood cholesterol [ Time Frame: 12 weeks ]
blood will be collected at baseline before the experimental foods are introduced and again 6 weeks into the intervention period and during the last week of the intervention (week 12)
Same as current
Complete list of historical versions of study NCT01564498 on ClinicalTrials.gov Archive Site
  • blood pressure [ Time Frame: 12 weeks ]
    Participants will have their body weight and blood pressure taken at weekly counselling sessions
  • body composition [ Time Frame: 12 weeks ]
    body composition will be measured in well hydrated subjects using bioelectric impedence analysis
  • insulin resistance [ Time Frame: 12 weeks ]
    insulin resistance will be measured by way of an oral glucose tolerance test and collection of venous blood samples for the subsequent 3 hours on two occasions, baseline and during the last week of the intervention diet.
  • blood and urinary polyphenol metabolites [ Time Frame: 12 weeks ]

    venous blood and urine will be collected to determine the metabolic profiles of polyphenolics in individual participants.

    Based on intake data, the bioavailability of the polyphenols in the foods will be estimated.

  • circulating biomarkers of cardiovascular disease and type II diabetes risk [ Time Frame: 12 weeks ]
    Blood will be collected for measurement of multiple cytokines, growth factors and other blood biomarkers associated with these diseases.
Same as current
Not Provided
Not Provided
 
Effects of Purple Vegetables on Cardiovascular Disease (CVD) Risk Factors
A Pilot Study of the Effects of Replacing Orange Carrots and White Potatoes With Purple Varieties, on Risk Factors for Cardiovascular Disease
The hypothesis is that richly coloured purple vegetables, rich in polyphenolic compounds including anthocyanins will have higher antioxidant and other biological activities, than more lightly coloured versions of these foods. Diets of human subjects will be modified to allow consumption of 200-300 g of raw carrots or cooked potatoes. Participants will be randomized to consume either orange or purple carrots, or white or purple potatoes. They will consume these diets for 12 weeks and bioavailability of polyphenolics will be examined as well as anthropometry and blood biochemistry for changes in risk factors associated with cardiovascular disease.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Hypertension
  • Hypercholesterolemia
  • Type II Diabetes
  • Obesity
  • Inflammation
Other: vegetable
200-300 g raw carrots or 300-500 g cooked potatoes
  • Placebo Comparator: White potato
    Participants will consume 300-500 g of cooked white potatoes per day
    Intervention: Other: vegetable
  • Experimental: Purple Potato
    Participants will consume 300-500 g of cooked purple potato per day
    Intervention: Other: vegetable
  • Placebo Comparator: Orange carrots
    Participants will consume 200-300 g typical varieties of orange carrots during the intervention
    Intervention: Other: vegetable
  • Experimental: Purple Carrots
    Participants will consume 200-300 g raw purple carrots instead of orange carrots in the control arm
    Intervention: Other: vegetable
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2017
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult men and women 18-65 years of age
  • must have a least one of the following risk factors associated with increased risk of type II diabetes and/or cardiovascular disease:

    • borderline high or hypertension or undergoing treatment for such
    • abnormal fasting blood glucose or undergoing treatment for such
    • overweight or obese
    • borderline high or high LDL-cholesterol or undergoing treatment for such
    • borderline low or low HDL-cholesterol
    • borderline high or high triglycerides or undergoing treatment for such

Exclusion Criteria:

  • smokers, pregnant or nursing women
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact: Kelly A Meckling, PhD 5198244120 ext 53742 kmecklin@uoguelph.ca
Contact: Saqib Mannan, BSc 5198244120 ext 53728 smannan@uoguelph.ca
Canada
 
 
NCT01564498
2012MeckPurpleVeg
No
Not Provided
Plan to Share IPD: No
Kelly Anne Meckling, PhD, University of Guelph
University of Guelph
Ontario Ministry of Agriculture, Food and Rural Affairs
Not Provided
University of Guelph
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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