Recruiting
Phase 1

Purple Vegetables

Sponsor:

University of Guelph

Code:

NCT01564498

Conditions

Hypertension

Hypercholesterolemia

Type II Diabetes

Obesity

Inflammation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

vegetable

Study Details

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.

Conditions

Hypertension

Hypercholesterolemia

Type II Diabetes

Obesity

Inflammation

Study ID

NCT01564498

Start date

Apr, 2012

Status verified date

Oct, 2016

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: White potato

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

experimental: Purple Potato

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

placebo comparator: Orange carrots

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

experimental: Purple Carrots

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

Interventions

vegetable

200-300 g raw carrots or 300-500 g cooked potatoes

Primary outcome measure

  • Blood cholesterol [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Kelly A Meckling, PhD

5198244120kmecklin@uoguelph.ca

Saqib Mannan, BSc

5198244120smannan@uoguelph.ca

Locations

Human Nutraceutical Research Unit

Recruiting

Guelph, Ontario, Canada, N1G2W1

Contacts

Amanda J Wright, PhD

5198244120ajwright@uoguelph.ca

Amy Tucker, PhD

5198244120

Principal Investigator:

Kelly A Meckling, PhD

More Information

Sponsor

University of Guelph

Last update posted

Oct 26, 2016

Last verified

Oct, 2016

Keywords

  • anthocyanins
  • antioxidant
  • polyphenols
  • bioavailability
  • cholesterol
  • insulin sensitivity
  • glucose tolerance
  • atherosclerosis
  • metabolic syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Guelph on 2016-10-26.