Barley Protein and CVD

Status:

COMPLETED

Barley Protein and CVD

Lead Sponsor:

University of Toronto

Conditions:

Hypercholesterolemia

Cardiovascular Disease

Eligibility:

All Genders

21+ years

Phase:

PHASE2

Brief Summary

The Question posed is: Does an barley protein concentrate have health benefits similar to those demonstrated for soy protein foods which would justify the use of the non-fiber components of barley as ...

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 an...

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00334308

Last Update

January 21 2009

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