Portfolio 5 - Multicentre Dietary Advice on Serum Lipids in Hyperlipidemia

NACompletedINTERVENTIONAL
Enrollment

351

Participants

Timeline

Start Date

June 25, 2007

Primary Completion Date

September 30, 2009

Study Completion Date

March 31, 2010

Conditions
HyperlipidemiaCardiovascular 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.

Trial Locations (5)

V6Z 1Y6

Healthy Heart Program, St. Paul's Hospital, Vancouver

R3T 6C5

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, Winnipeg

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5C 2T2

St. Michael's Hospital, Toronto

G1V 4G2

Institute on Nutraceuticals and Functional Foods and the Lipid Research Center, Laval University Hospital Research Center, Québec

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

Loblaw Companies Limited

INDUSTRY

collaborator

Solae, LLC

INDUSTRY

collaborator

Unilever R&D

INDUSTRY

lead

University of Toronto

OTHER

NCT00438425 - Portfolio 5 - Multicentre Dietary Advice on Serum Lipids in Hyperlipidemia | Biotech Hunter | Biotech Hunter