Portfolio 5 - Multicentre Dietary Advice on Serum Lipids in Hyperlipidemia

NCT00438425 | Completed

• 2 other identifiers: REB 04-056cCIHR RCT#: 68767
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Hyperlipidemia; Hypercholesterolemia; Dietary modification; Portfolio

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measures Described Below

  Plasma LDL-C concentrations

  December 2011

Secondary Outcomes (1)

• Secondary Outcome Measures Described Below

  January 2016 (anticipated)

Other Outcomes (1)

• Tertiary Outcome Measures Described Below

  January 2016 (anticipated)

Study Arms (3)

Intensive Portfolio

EXPERIMENTAL

The portfolio dietary advice will conform to current therapeutic diets appropriate for hypercholesterolemic subjects (\<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. Participants received 7 visits during a 6-month period with the study dietitian.

Dietary Supplement: Dietary Portfolio - Intensive

Routine Portfolio

EXPERIMENTAL

The portfolio dietary advice will conform to current therapeutic diets appropriate for hypercholesterolemic subjects (\<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. Participants received 2 visits during a 6-month period with the study dietitian.

Dietary Supplement: Dietary Portfolio - Routine

Control

ACTIVE COMPARATOR

Advice focused 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.

Dietary Supplement: Control (low saturated fat therapeutic diet)

Interventions

Dietary Portfolio - Intensive DIETARY_SUPPLEMENT

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.

Intensive Portfolio

Dietary Portfolio - Routine DIETARY_SUPPLEMENT

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.

Routine Portfolio

Control (low saturated fat therapeutic diet) DIETARY_SUPPLEMENT

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.

Control

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men over the age of 21 years and postmenopausal women with mild-to-moderate hypercholesterolaemia, for whom cholesterol lowering medications are being considered
• Body mass index \<35 kg/m2.
• Treated by diet
• Alcohol intake \< 14 drinks per week.
• Fasting plasma triglyceride (TG) concentration \<4.5 mmol/l.
• Fasting plasma LDL cholesterol concentration \> 4.1 mmol/l at diagnosis or within 30% of their target levels based on risk
• Patients with previous adverse effects on statins (e.g. muscle pains) will also be accepted if the physician responsible for their care considers it appropriate.
• Individuals who prior to cholesterol lowering therapy or after discontinuing cholesterol lowering therapy are within 30% of their treatment LDL-C goals may be permitted to enter the study with the approval of their responsible physician.
• Fit individuals who have had a myocardial infarction or cardiac bypass surgery in the past will not be excluded. Their responsible physician will be asked to provide a letter confirming their suitability for the study.

You may not qualify if:

• Premenopausal women will be excluded due to the fluctuation of blood lipids during the menstrual cycle.
• Patients will be excluded if they are taking cholesterol medications at the start of the study. However, with their physician's approval, those who wish to join but are already taking cholesterol-lowering medications may join the study providing the medications are stopped for one month before starting the study and throughout the study.
• Patients will be excluded if they are taking cholesterol lowering natural health products such as psyllium, red yeast rice, cholest, polycosanol etc. However, they will be allowed to join the study if they are willing to discontinue these products at least 2 weeks before the start of the study and throughout the study.
• Patients with uncontrolled high blood pressure will be excluded. The cut off for raised blood pressure has been taken as \> 140/90mmHg. Patients with systolic blood pressure between 140-150mmHg and diastolic blood pressure between 90-95mmHg may be accepted, since we have found that on the diet their blood pressures tend to be lowered into the acceptable range. For patients in the above normal range (as above), a letter will be required from the physician responsible for their care. Patients will be excluded if they change the type or dose of their blood pressure treatment during the study.
• Patients will be excluded if they are judged as having a likelihood of being non-compliant with instructions for whatever reason. Those with low compliance to lipid-lowering therapy will not be selected.
• Patients will be excluded if they have evidence or history of diabetes, renal disease, liver disease or gastrointestinal disease. Patients will be excluded if they have gross xanthoma or advanced premature cardiovascular disease since this group may include hyper-absorbers of plant sterols.
• Individuals predisposed to hemorrhagic stroke (on the basis of untreated raised blood pressure) will be excluded.
• Patients will be excluded from the study if they have a history of any form of cancer apart from non melanoma skin cancer or are considered at high risk for cancer. However, if such patients wish to join the study, we would like them to obtain the approval of their oncologist or responsible physician prior to enrollment in the study. If the study oncologist does not believe it is safe to enroll the participant, the patient will be excluded from the study.

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Loblaw Companies Limited: collaborator
• Solae, LLC: collaborator
• Unilever R&D: collaborator

Study Sites (5)

Healthy Heart Program, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, R3T 6C5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

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

Québec, Quebec, G1V 4G2, Canada

Location

Related Publications (11)

• Jenkins DJ, Kendall CW, Faulkner DA, Nguyen T, Kemp T, Marchie A, Wong JM, de Souza R, Emam A, Vidgen E, Trautwein EA, Lapsley KG, Holmes C, Josse RG, Leiter LA, Connelly PW, Singer W. Assessment of the longer-term effects of a dietary portfolio of cholesterol-lowering foods in hypercholesterolemia. Am J Clin Nutr. 2006 Mar;83(3):582-91. doi: 10.1093/ajcn.83.3.582.

  PMID: 16522904 BACKGROUND

• Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Josse AR, Wong JM, de Souza R, Emam A, Parker TL, Li TJ, Josse RG, Leiter LA, Singer W, Connelly PW. Direct comparison of dietary portfolio vs statin on C-reactive protein. Eur J Clin Nutr. 2005 Jul;59(7):851-60. doi: 10.1038/sj.ejcn.1602152.

  PMID: 15900306 BACKGROUND

• Jones PJ, Raeini-Sarjaz M, Jenkins DJ, Kendall CW, Vidgen E, Trautwein EA, Lapsley KG, Marchie A, Cunnane SC, Connelly PW. Effects of a diet high in plant sterols, vegetable proteins, and viscous fibers (dietary portfolio) on circulating sterol levels and red cell fragility in hypercholesterolemic subjects. Lipids. 2005 Feb;40(2):169-74. doi: 10.1007/s11745-005-1372-6.

  PMID: 15884765 BACKGROUND

• Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Wong JM, de Souza R, Emam A, Parker TL, Vidgen E, Trautwein EA, Lapsley KG, Josse RG, Leiter LA, Singer W, Connelly PW. Direct comparison of a dietary portfolio of cholesterol-lowering foods with a statin in hypercholesterolemic participants. Am J Clin Nutr. 2005 Feb;81(2):380-7. doi: 10.1093/ajcn.81.2.380.

  PMID: 15699225 BACKGROUND

• Lamarche B, Desroches S, Jenkins DJ, Kendall CW, Marchie A, Faulkner D, Vidgen E, Lapsley KG, Trautwein EA, Parker TL, Josse RG, Leiter LA, Connelly PW. Combined effects of a dietary portfolio of plant sterols, vegetable protein, viscous fibre and almonds on LDL particle size. Br J Nutr. 2004 Oct;92(4):657-63. doi: 10.1079/bjn20041241.

  PMID: 15522135 BACKGROUND

• Jenkins DJ, Kendall CW, Marchie A, Faulkner DA, Wong JM, de Souza R, Emam A, Parker TL, Vidgen E, Lapsley KG, Trautwein EA, Josse RG, Leiter LA, Connelly PW. Effects of a dietary portfolio of cholesterol-lowering foods vs lovastatin on serum lipids and C-reactive protein. JAMA. 2003 Jul 23;290(4):502-10. doi: 10.1001/jama.290.4.502.

  PMID: 12876093 BACKGROUND

• Jenkins DJ, Kendall CW, Faulkner D, Vidgen E, Trautwein EA, Parker TL, Marchie A, Koumbridis G, Lapsley KG, Josse RG, Leiter LA, Connelly PW. A dietary portfolio approach to cholesterol reduction: combined effects of plant sterols, vegetable proteins, and viscous fibers in hypercholesterolemia. Metabolism. 2002 Dec;51(12):1596-604. doi: 10.1053/meta.2002.35578.

  PMID: 12489074 BACKGROUND

• Hooper L, Abdelhamid AS, Jimoh OF, Bunn D, Skeaff CM. Effects of total fat intake on body fatness in adults. Cochrane Database Syst Rev. 2020 Jun 1;6(6):CD013636. doi: 10.1002/14651858.CD013636.

  PMID: 32476140 DERIVED

• Jenkins DJ, Jones PJ, Frohlich J, Lamarche B, Ireland C, Nishi SK, Srichaikul K, Galange P, Pellini C, Faulkner D, de Souza RJ, Sievenpiper JL, Mirrahimi A, Jayalath VH, Augustin LS, Bashyam B, Leiter LA, Josse R, Couture P, Ramprasath V, Kendall CW. The effect of a dietary portfolio compared to a DASH-type diet on blood pressure. Nutr Metab Cardiovasc Dis. 2015 Dec;25(12):1132-9. doi: 10.1016/j.numecd.2015.08.006. Epub 2015 Nov 6.

  PMID: 26552742 DERIVED

• Ramprasath VR, Jenkins DJ, Lamarche B, Kendall CW, Faulkner D, Cermakova L, Couture P, Ireland C, Abdulnour S, Patel D, Bashyam B, Srichaikul K, de Souza RJ, Vidgen E, Josse RG, Leiter LA, Connelly PW, Frohlich J, Jones PJ. Consumption of a dietary portfolio of cholesterol lowering foods improves blood lipids without affecting concentrations of fat soluble compounds. Nutr J. 2014 Oct 18;13:101. doi: 10.1186/1475-2891-13-101.

  PMID: 25326876 DERIVED

• Jenkins DJ, Jones PJ, Lamarche B, Kendall CW, Faulkner D, Cermakova L, Gigleux I, Ramprasath V, de Souza R, Ireland C, Patel D, Srichaikul K, Abdulnour S, Bashyam B, Collier C, Hoshizaki S, Josse RG, Leiter LA, Connelly PW, Frohlich J. Effect of a dietary portfolio of cholesterol-lowering foods given at 2 levels of intensity of dietary advice on serum lipids in hyperlipidemia: a randomized controlled trial. JAMA. 2011 Aug 24;306(8):831-9. doi: 10.1001/jama.2011.1202.

  PMID: 21862744 DERIVED

MeSH Terms

Conditions

Hyperlipidemias; Cardiovascular Diseases; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• David J.A. Jenkins, MD, PhD

  University of Toronto, St. Michael's Hospital

  PRINCIPAL INVESTIGATOR

• Cyril W.C. Kendall, PhD

  University of Toronto, St. Michael's Hospital

  STUDY DIRECTOR

• Dorothea Faulkner, PhD

  Unity Health Toronto

  STUDY CHAIR

• Benoit Lamarche, PhD

  Lipid Research Clinic & Institute on Nutraceuticals and Functional Foods, Laval University

  STUDY DIRECTOR

• Peter Jones, PhD

  Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

  STUDY DIRECTOR

• Jiri Frohlich, MD

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

  STUDY DIRECTOR

• Jay Silverberg, MD

  Sunnybrooke Health Science Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 21, 2007
• First Posted: February 22, 2007
• Study Start: June 25, 2007
• Primary Completion: September 30, 2009
• Study Completion: March 31, 2010
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

CA (5)