- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00334308
Barley Protein and CVD
Barley Protein and Coronary Heart Disease Risk Reduction
Study Overview
Status
Intervention / Treatment
Detailed Description
Design: The effect of oat protein extract will be assessed in one-month feeding studies of forty healthy men and women with raised serum cholesterol levels. Two breads will be prepared, one control and one providing 45 g/d barley protein to be fed for one month each in a randomized crossover design.
Diets: The diets will be the subjects' usual diets which appropriately will be NCEP Step 2 diets for patients treated without medications with this degree of hyperlipidemia. Those who are not on an NCEP Step 2 diet will be instructed accordingly. During the first phase, the two one-week recorded diets for each patient will be photocopied and returned to the patient to be used as the dietary model for the subsequent period. We have found that this approach is effective in stabilizing the diets in our soy protein studies. Supplements: Will be breads with test and control supplements providing the identical daily energy intake. The increase in protein in the barley supplements will be matched by the use of protein from milk protein (casein). Similarly the increased polyunsaturated, monounsaturated and saturated fatty acids in the test supplement will be matched by addition of an appropriate blend of oils in the control. Baked goods will be prepared at our clinic and a seven-day supply will be provided to each participant at the beginning of each week. The exact formulation of the supplements will involve product development, palatability testing and chemical analysis of the prototypes in the initial phase of the study. Compliance: compliance will be assessed from completed weekly diet records where supplement intake is recorded daily. These records will be reviewed by a dietitian with the subject at the end of the week. In addition, uneaten supplements will be returned, weighed and noted on the menu plans by the dietitian. Diet records will also be assessed to ensure the predetermined diet plan is followed according to the phase one recorded diet.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5C 2T2
- St. Michael's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- men and postmenopausal women with mild- to-moderate hypercholesterolemia
- Body mass index >18 kg/m2 and < 36 kg/m2.
- treated by diet
- Alcohol intake < 14 drinks per week.
- Fasting plasma triglyceride (TG) concentration > 0.5 mmol/l and < 4.5 mmol/l.
- Fasting plasma LDL cholesterol concentration > 3.5 mmol/l at diagnosis.
Exclusion Criteria:
- Child-bearing women
- Taking cholesterol lowering medications at the start of the study, unless their LDL-cholesterol levels are >3.5 mmol/L.However, with their physician's approval those who wish to join but are already taking cholesterol lowering medications with low LDL-cholesterol levels (e.g. <2.5 mmol/L) may join the study providing the medications are stopped for one month.
- Change the type or dose of their drug treatment during the study
- Patients judged as having a likelihood of being non-compliant with instructions for whatever reason
- Food allergies
- Evidence or history of diabetes, renal liver disease or gastrointestinal disease
- Recent (within 6 months)) major cardiovascular event (stroke or myocardial infarction)
- Secondary causes of hypercholesterolemia (or untreated hypothyroidism)
- Uncontrolled blood pressure
- Major disability or disorder such as liver disease, renal failure or cancer or with major surgery < 6 months prior to randomization
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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total and LDL cholesterol, LDL:HDL cholesterol ratio
|
Secondary Outcome Measures
Outcome Measure |
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Blood pressure, HDL cholesterol, HDL2 and HDL3, triglyceride, apolipoprotein A1 and B, Lp(a) and LDL particle size; oxidative stress,inflammatory biomarkers
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David JA Jenkins, MD, University of Toronto
Publications and helpful links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB 02-113C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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