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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension, Hypercholesterolemia, Type II Diabetes, Obesity, Inflammation

Intervention / Treatment
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* Other: vegetable


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anthocyanins, antioxidant, polyphenols, bioavailability, cholesterol, insulin sensitivity, glucose tolerance, atherosclerosis, metabolic syndrome