A Phase 1 interventional study of vegetable in Hypertension, Hypercholesterolemia and Type II Diabetes, sponsored by University of Guelph. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-10-26.
Sponsored by University of Guelph · Phase 1, Interventional, and Prevention
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.
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This study's planned enrollment of 60 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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must have a least one of the following risk factors associated with increased risk of type II diabetes and/or cardiovascular disease:
Exclusion Criteria:
Participants will consume 300-500 g of cooked white potatoes per day
Other: vegetable
Participants will consume 300-500 g of cooked purple potato per day
Other: vegetable
Participants will consume 200-300 g typical varieties of orange carrots during the intervention
Other: vegetable
Participants will consume 200-300 g raw purple carrots instead of orange carrots in the control arm
Other: vegetable
200-300 g raw carrots or 300-500 g cooked potatoes
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)
Time frame: 12 weeks
blood pressure
Participants will have their body weight and blood pressure taken at weekly counselling sessions
Time frame: 12 weeks
body composition
body composition will be measured in well hydrated subjects using bioelectric impedence analysis
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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University of Guelph