Cardiovascular DiseasePhase 2NCT00839774
Effect of Pulse Fractions on Indices on Cardiovascular Disease and Diabetes Risk Factors
A Phase 2 study testing Whole yellow pea flour, Fractionated pea flour and White wheat flour in people with Cardiovascular Disease, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to determine if whole and fractionated yellow pea flour, administered at USDA recommended dosages (50 g/day), improve risk factors associated with cardiovascular disease and diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Whole yellow pea flour, Fractionated pea flour and White wheat flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2007to Mar 2008
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI between 25 and 40 kg/m2
- Hypercholesterolemic
Who cannot join
- Smoking
- Use of prescription and natural lipid lowering therapies
- Myocardial infarction
- Coronary artery bypass
- Angina
- Congestive heart failure,
Show all 14Show fewer
- Inflammatory bowel disease
- Pancreatitis
- Renal disease
- Diabetes
- Chronic alcohol usage (> 2 drinks/day).
- Cancer
- Eating disorders
- Expending > 4000 kcal/week through exercise
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2
About this study
Official title: Effect of Pulse Fractions on Indices of Lipid, Carbohydrate and Energy Metabolism as Well as Oxidative Status in Overweight, Hyperlipidemic Individuals
The purpose of this study is to determine if whole and fractionated yellow pea flour, administered at USDA recommended dosages (50 g/day), improve risk factors associated with cardiovascular disease and diabetes.
- Conditions
- Cardiovascular Disease
- Being tested
- Whole yellow pea flour, Fractionated pea flour, White wheat flour
- Keywords
- Peas, Cardiovascular, Diabetes, Insulin, Insulin resistance, Abdominal fat
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole yellow pea flourOther
Whole pea flour was administered at 50 g/day.
Fractionated pea flourOther
Fractionated pea flour was administered according to the level of fiber in whole pea flour treatment. 12 g/day
White wheat flourOther
White wheat flour will be administered at 50 g/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Whole yellow pea flour Receives: Other: Whole yellow pea flour |
| 2 | Experimental | Fractionated yellow pea flour Receives: Other: Fractionated pea flour |
| 3 | Experimental | White wheat flour Receives: Other: White wheat flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid levels
Measured: Day 1 & 2 and Day 28 & 29 of each treatment phase
Postprandial glucose response
Measured: During week 1 and week 4 of each treatment phase
Fasting Insulin
Measured: Day 1 & 2 and Day 28 & 29 of each treatment phase
Insulin homeostasis modeling assessment
Measured: Day 1 & 2 and Day 28 & 29 of each treatment phase
Energy expenditure
Measured: During week 1 and week 4 of each treatment phase
body composition
Measured: Day 1 and Day 29 of each treatment phase
Antioxidant status
Measured: Day 1 & 2 and Day 28 & 29 of each treatment phase
Postprandial substrate utilization
Postprandial dietary fatty acid oxidation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startFeb 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Pulse Canada
- Investigators
- Peter J.H. Jones, PhD, Principal investigator, University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839774
- Sponsor's protocol ID
- B2006:129
- Status last verified
- Aug 2008
- First submitted
- 6 Feb 2009
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulse Fractions on Indices of Lipid, Carbohydrate and Energy Metabolism as Well as Oxidative Status in Overweight, Hyperlipidemic Individuals
- ClinicalTrials.gov ID
- NCT00839774
- Acronym / sponsor ID
- B2006:129
- Conditions
- Cardiovascular Disease
- Keywords
- Peas, Cardiovascular, Diabetes, Insulin, Insulin resistance, Abdominal fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Pulse Canada
- Study start
- Feb 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 10 Feb 2009 (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 purpose of this study is to determine if whole and fractionated yellow pea flour, administered at USDA recommended dosages (50 g/day), improve risk factors associated with cardiovascular disease and diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Whole yellow pea flourWhole yellow pea flour |
| 2 | Experimental | Other: Fractionated pea flourFractionated yellow pea flour |
| 3 | Experimental | Other: White wheat flourWhite wheat flour |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI between 25 and 40 kg/m2
- Hypercholesterolemic
Key exclusion criteria (14 listed)
- Smoking
- Use of prescription and natural lipid lowering therapies
- Myocardial infarction
- Coronary artery bypass
- Angina
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 |
|---|---|---|
| Whole yellow pea flourWhole pea flour was administered at 50 g/day. | Other | 1 |
| Fractionated pea flourFractionated pea flour was administered according to the level of fiber in whole pea flour treatment. 12 g/day | Other | 2 |
| White wheat flourWhite wheat flour will be administered at 50 g/day | Other | 3 |
Primary outcome
Lipid levels
Time frame: Day 1 & 2 and Day 28 & 29 of each treatment phase
Postprandial glucose response
Time frame: During week 1 and week 4 of each treatment phase
Fasting Insulin
Time frame: Day 1 & 2 and Day 28 & 29 of each treatment phase
Insulin homeostasis modeling assessment
Time frame: Day 1 & 2 and Day 28 & 29 of each treatment phase
Energy expenditure
Time frame: During week 1 and week 4 of each treatment phase
body composition
Time frame: Day 1 and Day 29 of each treatment phase
Antioxidant status
Time frame: Day 1 & 2 and Day 28 & 29 of each treatment phase
Postprandial substrate utilization
Postprandial dietary fatty acid oxidation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
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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.
Peter J.H. Jones, PhD principal investigator
University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Whole yellow pea flour, Fractionated pea flour and White wheat flour in people with Cardiovascular Disease, run by University of Manitoba 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 2 inclusion and 14 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: finished, as of the sponsor's last update on 22 Jun 2010. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid levels (time frame: Day 1 & 2 and Day 28 & 29 of each treatment phase). The study lists 9 primary outcomes in all. 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 22 Jun 2010.