Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01564498
Other study ID # 2012MeckPurpleVeg
Secondary ID
Status Recruiting
Phase Phase 1
First received March 22, 2012
Last updated October 24, 2016
Start date April 2012
Est. completion date December 2017

Study information

Verified date October 2016
Source University of Guelph
Contact Kelly A Meckling, PhD
Phone 5198244120
Email kmecklin@uoguelph.ca
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Other:
vegetable
200-300 g raw carrots or 300-500 g cooked potatoes

Locations

Country Name City State
Canada Human Nutraceutical Research Unit Guelph Ontario

Sponsors (2)

Lead Sponsor Collaborator
University of Guelph Ontario Ministry of Agriculture, Food and Rural Affairs

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary blood pressure Participants will have their body weight and blood pressure taken at weekly counselling sessions 12 weeks No
Secondary body composition body composition will be measured in well hydrated subjects using bioelectric impedence analysis 12 weeks No
Secondary 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 No
Secondary 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 No
Secondary 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 No
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2