NCT01564498

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_1 hypertension

Timeline
Completed

Started Apr 2012

Longer than P75 for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

5.7 years

First QC Date

March 22, 2012

Last Update Submit

October 24, 2016

Conditions

HypertensionHypercholesterolemiaType II DiabetesObesityInflammation

Keywords

anthocyaninsantioxidantpolyphenolsbioavailabilitycholesterolinsulin sensitivityglucose toleranceatherosclerosismetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • blood pressure

    12 weeks

  • body composition

    12 weeks

  • insulin resistance

    12 weeks

  • blood and urinary polyphenol metabolites

    12 weeks

  • circulating biomarkers of cardiovascular disease and type II diabetes risk

    12 weeks

Study Arms (4)

White potato

PLACEBO COMPARATOR

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

Other: vegetable

Purple Potato

EXPERIMENTAL

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

Other: vegetable

Orange carrots

PLACEBO COMPARATOR

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

Other: vegetable

Purple Carrots

EXPERIMENTAL

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

Other: vegetable

Interventions

vegetableOTHER

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

Orange carrotsPurple CarrotsPurple PotatoWhite potato

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • smokers, pregnant or nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutraceutical Research Unit

Guelph, Ontario, N1G2W1, Canada

RECRUITING

MeSH Terms

Conditions

HypertensionHypercholesterolemiaDiabetes Mellitus, Type 2ObesityInflammationInsulin ResistanceAtherosclerosisMetabolic Syndrome

Interventions

Vegetables

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusGlucose Metabolism DisordersEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesHyperinsulinismArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Kelly A Meckling, PhD

CONTACT

5198244120kmecklin@uoguelph.ca

Saqib Mannan, BSc

CONTACT

5198244120smannan@uoguelph.ca

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2012

First Posted

March 27, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 26, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)