HypertensionPhase 1NCT01564498
Effects of Purple Vegetables on Cardiovascular Disease (CVD) Risk Factors
A Phase 1 study testing vegetable in people with Hypertension and Hypercholesterolemia, run by University of Guelph at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Hypercholesterolemia, Type II Diabetes
- What is being tested?
- vegetable
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2012to Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- smokers, pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Human Nutraceutical Research Unit
Guelph, Ontario, N1G2W1
Amanda J Wright, PhD, 5198244120 ext. 54697, ajwright@uoguelph.ca
Amy Tucker, PhD, 5198244120 ext. 53925
About this study
Official title: A Pilot Study of the Effects of Replacing Orange Carrots and White Potatoes With Purple Varieties, on Risk Factors for Cardiovascular Disease
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
- Being tested
- vegetable
- Keywords
- anthocyanins, antioxidant, polyphenols, bioavailability, cholesterol, insulin sensitivity, glucose tolerance, atherosclerosis, metabolic syndrome
- Medical subject headings
- Hypertension, Hypercholesterolemia, Diabetes Mellitus, Type 2, Obesity, Inflammation, Insulin Resistance, Atherosclerosis, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vegetableOther
200-300 g raw carrots or 300-500 g cooked potatoes
| Study group | Role | What they receive |
|---|---|---|
| White potato | Placebo comparator | Participants will consume 300-500 g of cooked white potatoes per day Receives: Other: vegetable |
| Purple Potato | Experimental | Participants will consume 300-500 g of cooked purple potato per day Receives: Other: vegetable |
| Orange carrots | Placebo comparator | Participants will consume 200-300 g typical varieties of orange carrots during the intervention Receives: Other: vegetable |
| Purple Carrots | Experimental | Participants will consume 200-300 g raw purple carrots instead of orange carrots in the control arm Receives: Other: vegetable |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (5)
blood pressure
Participants will have their body weight and blood pressure taken at weekly counselling sessions
Measured: 12 weeks
body composition
body composition will be measured in well hydrated subjects using bioelectric impedence analysis
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Agriculture, Food and Rural Affairs
- Responsible party
- Principal investigator, Kelly Anne Meckling, PhD, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564498
- Sponsor's protocol ID
- 2012MeckPurpleVeg
- Status last verified
- Oct 2016
- First submitted
- 22 Mar 2012
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effects of Replacing Orange Carrots and White Potatoes With Purple Varieties, on Risk Factors for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT01564498
- Acronym / sponsor ID
- 2012MeckPurpleVeg
- Conditions
- Hypertension, Hypercholesterolemia, Type II Diabetes, Obesity, Inflammation
- Keywords
- anthocyanins, antioxidant, polyphenols, bioavailability, cholesterol, insulin sensitivity, glucose tolerance, atherosclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Ontario Ministry of Agriculture, Food and Rural Affairs
- Study start
- Apr 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| White potato | Placebo comparator | Other: vegetableParticipants will consume 300-500 g of cooked white potatoes per day |
| Purple Potato | Experimental | Other: vegetableParticipants will consume 300-500 g of cooked purple potato per day |
| Orange carrots | Placebo comparator | Other: vegetableParticipants will consume 200-300 g typical varieties of orange carrots during the intervention |
| Purple Carrots | Experimental | Other: vegetableParticipants will consume 200-300 g raw purple carrots instead of orange carrots in the control arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (1 listed)
- smokers, pregnant or nursing women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vegetable200-300 g raw carrots or 300-500 g cooked potatoes | Other | Orange carrots, Purple Carrots, Purple Potato, White potato |
Primary outcome
Blood cholesterol
Time frame: 12 weeks
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)
5 secondary outcomes
blood pressure
Time frame: 12 weeks
body composition
Time frame: 12 weeks
insulin resistance
Time frame: 12 weeks
blood and urinary polyphenol metabolites
Time frame: 12 weeks
circulating biomarkers of cardiovascular disease and type II diabetes risk
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vegetable in people with Hypertension and Hypercholesterolemia, run by University of Guelph at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly A Meckling, PhD (5198244120 ext. 53742, kmecklin@uoguelph.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood cholesterol (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.