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

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ClinicalTrials.gov Identifier: NCT01564498
Recruitment Status : Unknown
Verified October 2016 by Kelly Anne Meckling, PhD, University of Guelph.
Recruitment status was:  Recruiting
First Posted : March 27, 2012
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Ontario Ministry of Agriculture, Food and Rural Affairs
Information provided by (Responsible Party):
Kelly Anne Meckling, PhD, University of Guelph

Tracking Information
First Submitted Date  ICMJE March 22, 2012
First Posted Date  ICMJE March 27, 2012
Last Update Posted Date October 26, 2016
Study Start Date  ICMJE April 2012
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Purple Vegetables on Cardiovascular Disease (CVD) Risk Factors
Official Title  ICMJE A Pilot Study of the Effects of Replacing Orange Carrots and White Potatoes With Purple Varieties, on Risk Factors for Cardiovascular Disease
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Hypertension
  • Hypercholesterolemia
  • Type II Diabetes
  • Obesity
  • Inflammation
Intervention  ICMJE Other: vegetable
200-300 g raw carrots or 300-500 g cooked potatoes
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 23, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01564498
Other Study ID Numbers  ICMJE 2012MeckPurpleVeg
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kelly Anne Meckling, PhD, University of Guelph
Study Sponsor  ICMJE University of Guelph
Collaborators  ICMJE Ontario Ministry of Agriculture, Food and Rural Affairs
Investigators  ICMJE Not Provided
PRS Account University of Guelph
Verification Date October 2016

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