Portfolio 5 - Multicentre Dietary Advice on Serum Lipids in Hyperlipidemia

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.

Conditions

• Hyperlipidemia
• Cardiovascular Disease

Interventions

DIETARY_SUPPLEMENT

Dietary Portfolio - Intensive

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.

DIETARY_SUPPLEMENT

Dietary Portfolio - Routine

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.

DIETARY_SUPPLEMENT

Control (low saturated fat therapeutic diet)

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.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Loblaw Companies Limited

  collaborator INDUSTRY

• Solae, LLC

  collaborator INDUSTRY

• Unilever R&D

  collaborator INDUSTRY

• University of Toronto

  lead OTHER

Principal Investigators

• David J.A. Jenkins, MD, PhD · University of Toronto, St. Michael's Hospital

• Cyril W.C. Kendall, PhD · University of Toronto, St. Michael's Hospital

• Dorothea Faulkner, PhD · Unity Health Toronto

• Benoit Lamarche, PhD · Lipid Research Clinic & Institute on Nutraceuticals and Functional Foods, Laval University

• Peter Jones, PhD · Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

• Jiri Frohlich, MD · Healthy Heart Program, St. Paul's Hospital, Vancouver BC.

• Jay Silverberg, MD · Sunnybrooke Health Science Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-06-25

Primary Completion

2009-09-30

Completion

2010-03-31

Countries

• Canada

Study Locations