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

Obesity Clinical Trial

Official title:

A Pilot Study of the Effects of Replacing Orange Carrots and White Potatoes With Purple Varieties, on Risk Factors for Cardiovascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01564498
• Other study ID #: 2012MeckPurpleVeg
• Status: Recruiting
• Phase: Phase 1
• First received: March 22, 2012
• Last updated: October 24, 2016
• Start date: April 2012
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: University of Guelph
• Contact: Kelly A Meckling, PhD
• Phone: 5198244120
• Email: kmecklin[@]uoguelph.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Hypercholesterolemia
• Hypertension
• Inflammation
• Obesity
• Type II Diabetes

Intervention

Other:
• vegetable
200-300 g raw carrots or 300-500 g cooked potatoes

Locations

Country	Name	City	State
Canada	Human Nutraceutical Research Unit	Guelph	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Guelph	Ontario Ministry of Agriculture, Food and Rural Affairs

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 weeks	No
Secondary	blood pressure	Participants will have their body weight and blood pressure taken at weekly counselling sessions	12 weeks	No
Secondary	body composition	body composition will be measured in well hydrated subjects using bioelectric impedence analysis	12 weeks	No
Secondary	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.	12 weeks	No
Secondary	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.	12 weeks	No
Secondary	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.	12 weeks	No