Barley Protein and CVD

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.

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