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

Primary Purpose

Hypertension, Hypercholesterolemia, Type II Diabetes

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
vegetable
Sponsored by
University of Guelph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring anthocyanins, antioxidant, polyphenols, bioavailability, cholesterol, insulin sensitivity, glucose tolerance, atherosclerosis, metabolic syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Human Nutraceutical Research UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

White potato

Purple Potato

Orange carrots

Purple Carrots

Arm Description

Participants will consume 300-500 g of cooked white potatoes per day

Participants will consume 300-500 g of cooked purple potato per day

Participants will consume 200-300 g typical varieties of orange carrots during the intervention

Participants will consume 200-300 g raw purple carrots instead of orange carrots in the control arm

Outcomes

Primary Outcome Measures

Blood cholesterol
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)

Secondary Outcome Measures

blood pressure
Participants will have their body weight and blood pressure taken at weekly counselling sessions
body composition
body composition will be measured in well hydrated subjects using bioelectric impedence analysis
insulin resistance
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
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
Blood will be collected for measurement of multiple cytokines, growth factors and other blood biomarkers associated with these diseases.

Full Information

First Posted
March 22, 2012
Last Updated
October 24, 2016
Sponsor
University of Guelph
Collaborators
Ontario Ministry of Agriculture, Food and Rural Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT01564498
Brief Title
Effects of Purple Vegetables on Cardiovascular Disease (CVD) Risk Factors
Official Title
A Pilot Study of the Effects of Replacing Orange Carrots and White Potatoes With Purple Varieties, on Risk Factors for Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph
Collaborators
Ontario Ministry of Agriculture, Food and Rural Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hypercholesterolemia, Type II Diabetes, Obesity, Inflammation
Keywords
anthocyanins, antioxidant, polyphenols, bioavailability, cholesterol, insulin sensitivity, glucose tolerance, atherosclerosis, metabolic syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
White potato
Arm Type
Placebo Comparator
Arm Description
Participants will consume 300-500 g of cooked white potatoes per day
Arm Title
Purple Potato
Arm Type
Experimental
Arm Description
Participants will consume 300-500 g of cooked purple potato per day
Arm Title
Orange carrots
Arm Type
Placebo Comparator
Arm Description
Participants will consume 200-300 g typical varieties of orange carrots during the intervention
Arm Title
Purple Carrots
Arm Type
Experimental
Arm Description
Participants will consume 200-300 g raw purple carrots instead of orange carrots in the control arm
Intervention Type
Other
Intervention Name(s)
vegetable
Intervention Description
200-300 g raw carrots or 300-500 g cooked potatoes
Primary Outcome Measure Information:
Title
Blood cholesterol
Description
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)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
blood pressure
Description
Participants will have their body weight and blood pressure taken at weekly counselling sessions
Time Frame
12 weeks
Title
body composition
Description
body composition will be measured in well hydrated subjects using bioelectric impedence analysis
Time Frame
12 weeks
Title
insulin resistance
Description
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.
Time Frame
12 weeks
Title
blood and urinary polyphenol metabolites
Description
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.
Time Frame
12 weeks
Title
circulating biomarkers of cardiovascular disease and type II diabetes risk
Description
Blood will be collected for measurement of multiple cytokines, growth factors and other blood biomarkers associated with these diseases.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly A Meckling, PhD
Phone
5198244120
Ext
53742
Email
kmecklin@uoguelph.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Saqib Mannan, BSc
Phone
5198244120
Ext
53728
Email
smannan@uoguelph.ca
Facility Information:
Facility Name
Human Nutraceutical Research Unit
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G2W1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda J Wright, PhD
Phone
5198244120
Ext
54697
Email
ajwright@uoguelph.ca
First Name & Middle Initial & Last Name & Degree
Amy Tucker, PhD
Phone
5198244120
Ext
53925
First Name & Middle Initial & Last Name & Degree
Kelly A Meckling, PhD
First Name & Middle Initial & Last Name & Degree
Saqib Mannan, BSc
First Name & Middle Initial & Last Name & Degree
Ricky Janssen, BSc

12. IPD Sharing Statement

Plan to Share IPD
No

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

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