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

Phase 1

• Conditions: Hypercholesterolemia; Hypertension; Obesity; Inflammation; Type II Diabetes

• Registration Number: NCT01564498
• Lead Sponsor: University of Guelph

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 available

Study Timeline

• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Study Start: 2012-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood cholesterol	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)

Secondary Outcome Measures

Name	Time	Method
blood pressure	12 weeks	Participants will have their body weight and blood pressure taken at weekly counselling sessions
body composition	12 weeks	body composition will be measured in well hydrated subjects using bioelectric impedence analysis
insulin resistance	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	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	12 weeks	Blood will be collected for measurement of multiple cytokines, growth factors and other blood biomarkers associated with these diseases.

Trial Locations

Locations (1)

Human Nutraceutical Research Unit; 🇨🇦 Guelph, Ontario, Canada