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

October 24, 2016 updated by: Kelly Anne Meckling, PhD, University of Guelph

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Guelph, Ontario, Canada, N1G2W1
        • Recruiting
        • Human Nutraceutical Research Unit
        • Contact:
        • Contact:
          • Amy Tucker, PhD
          • Phone Number: 53925 5198244120
        • Principal Investigator:
          • Kelly A Meckling, PhD
        • Sub-Investigator:
          • Saqib Mannan, BSc
        • Sub-Investigator:
          • Ricky Janssen, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: White potato
Participants will consume 300-500 g of cooked white potatoes per day
Other: vegetable
200-300 g raw carrots or 300-500 g cooked potatoes
Experimental: Purple Potato
Participants will consume 300-500 g of cooked purple potato per day
Other: vegetable
200-300 g raw carrots or 300-500 g cooked potatoes
Placebo Comparator: Orange carrots
Participants will consume 200-300 g typical varieties of orange carrots during the intervention
Other: vegetable
200-300 g raw carrots or 300-500 g cooked potatoes
Experimental: Purple Carrots
Participants will consume 200-300 g raw purple carrots instead of orange carrots in the control arm
Other: vegetable
200-300 g raw carrots or 300-500 g cooked potatoes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure
Time Frame: 12 weeks
Participants will have their body weight and blood pressure taken at weekly counselling sessions
12 weeks
body composition
Time Frame: 12 weeks
body composition will be measured in well hydrated subjects using bioelectric impedence analysis
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guelph

Collaborators

Ontario Ministry of Agriculture, Food and Rural Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012MeckPurpleVeg

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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