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

U

University of Guelph

Status and phase

Unknown
Phase 1

Conditions

Hypertension
Inflammation
Type II Diabetes
Hypercholesterolemia
Obesity

Treatments

Other: vegetable

Study type

Interventional

Funder types

Other

Identifiers

NCT01564498
2012MeckPurpleVeg

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 4 patient groups, including a placebo group

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

Trial contacts and locations

1

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Central trial contact

Kelly A Meckling, PhD; Saqib Mannan, BSc

Data sourced from clinicaltrials.gov

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