At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Assessment of the Practical Application, Acceptability and Effectiveness of a Portfolio Diet in Reducing Serum Cholesterol
In Brief
A clinical study evaluating Dietary Portfolio - Intensive, Dietary Portfolio - Routine, and 1 other intervention for Hyperlipidemia and Cardiovascular Disease. Completed, enrolled 351 participants across 5 sites.
Detailed Summary
The purpose of this trial is to re-evaluate the potential role of diet in modulating cardiovascular risk factors. If potent lipid-lowering effects through novel dietary interventions can be demonstrated, then diet may again be seen as providing an alternative to drug therapy in the primary prevention of cardiovascular disease. Aims: * To determine the percentage of lipid clinic attendees interested in making a serious dietary change. * To determine the extent to which a self selected dietary portfolio combining viscous fiber foods (oat \& barley β-glucan, psyllium, etc.), soy and vegetable protein foods (soy milk, soy meat analogues and almonds) and plant sterols (sterol margarine) in the same diet be significantly more effective in reducing LDL-cholesterol and other markers of cardiovascular disease risk than conventional dietary advice. * To determine whether this effect can be maximized by more frequent follow-up, and what, if any, would be the relationship between dietary compliance and reduction in LDL-C.
Study Details
Timeline
Interventions
Dietitians advised participants to consume the following therapeutic diet components (\<7% of energy saturated fat, \<200 mg/d cholesterol) plus the combination of viscous fibers, soy protein, plant sterols and nuts. The portfolio diet plan will include foods which contribute 9.8 g/1000 kcal viscous fiber as B-glucan (oats, barley, oat bran breads and soups) and psylliium (cereal), 0.94 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers, dogs, links, other meat analogues, milks, yogurts and cheese) and 22.5 g nuts/1000 kcal as part of a low fat vegetarian diet. Participants received 7 visits during a 6-month period with the study dietitian.
Dietitians advised participants to consume the following therapeutic diet components (\<7% of energy saturated fat, \<200 mg/d cholesterol) plus the combination of viscous fibers, soy protein, plant sterols and nuts. The portfolio diet plan will include foods which contribute 9.8 g/1000 kcal viscous fiber as B-glucan (oats, barley, oat bran breads and soups) and psylliium (cereal), 0.94 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers, dogs, links, other meat analogues, milks, yogurts and cheese) and 22.5 g nuts/1000 kcal as part of a low fat vegetarian diet. Participants received 2 visits during a 6-month period with the study dietitian.
Dietitians advised participants to consume the following therapeutic diet components (\<7% of energy saturated fat, \<200 mg/d cholesterol) with a focus on low-fat dairy and whole grain cereals together with fruit and vegetables as part of a low fat vegetarian diet, and avoidance of the specific portfolio components.