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Meta-analysis of the Portfolio Dietary Pattern and Cardiometabolic Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03534414
Recruitment Status : Unknown
Verified May 2018 by John Sievenpiper, University of Toronto.
Recruitment status was:  Active, not recruiting
First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Information provided by (Responsible Party):
John Sievenpiper, University of Toronto

Brief Summary:
The European Association for the Study of Diabetes (EASD) guidelines have not made any specific recommendations regarding the Portfolio diet, a dietary pattern that includes nuts, viscous fibre, plant protein, and plant sterols. To update the recommendations, the Diabetes and Nutrition Study Group (DNSG) of the EASD commissioned a systematic review and meta-analysis using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to summarize the available evidence from controlled trials of the effect of the Portfolio dietary pattern on LDL-cholesterol (LDL-C) and other established cardiometabolic risk factors.

Condition or disease Intervention/treatment
Cardiovascular Risk Factor Cholesterol; Lipidosis Dietary Supplement: Portfolio Dietary Pattern Dietary Supplement: NCEP Based Diet

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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Effect of a Portfolio Dietary Pattern on Cardiometabolic Risk: A Systematic Review and Meta-analysis of Controlled Trials
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
A Portfolio Dietary Pattern involving a combination of 4 cholesterol lowering foods, namely: plant sterols, viscous fibre, plant protein, and nuts.
Dietary Supplement: Portfolio Dietary Pattern

Portfolio Dietary Pattern consisting of 4 food components, including:

  1. plant sterols (sterol-enriched margarine or supplement)
  2. viscous soluble fibres (oats, barley, psyllium, eggplant, okra, etc)
  3. plant protein (soy products and pulses), and
  4. nuts (tree nuts and peanuts)
Other Names:
  • Dietary Portfolio
  • Portfolio Diet

Dietary Supplement: NCEP Based Diet
A low saturated fat, low cholesterol diet.

A National Cholesterol Education Program (NCEP) based diet, a diet low in saturated fat and cholesterol.
Dietary Supplement: NCEP Based Diet
A low saturated fat, low cholesterol diet.

Primary Outcome Measures :
  1. Blood lipids - LDL-C [ Time Frame: Up to 20 years ]

Secondary Outcome Measures :
  1. Blood lipids - Total-C [ Time Frame: Up to 20 years ]
  2. Blood lipids - HDL-C [ Time Frame: Up to 20 years ]
  3. Blood lipids - non-HDL-C [ Time Frame: Up to 20 years ]
  4. Blood lipids - triglycerides [ Time Frame: Up to 20 years ]
  5. Blood lipids - Apolipoprotein B (apo B) [ Time Frame: Up to 20 years ]
  6. Adiposity - body weight [ Time Frame: Up to 20 years ]
  7. Inflammation - C-reactive protein [ Time Frame: Up to 20 years ]
  8. Blood pressure - systolic blood pressure [ Time Frame: Up to 20 years ]
  9. Blood pressure - diastolic blood pressure [ Time Frame: Up to 20 years ]
  10. Glycemic control - fasting blood glucose [ Time Frame: Up to 20 years ]
  11. Glycemic control - fasting blood insulin [ Time Frame: Up to 20 years ]
  12. Glycemic control - HbA1c [ Time Frame: Up to 20 years ]
  13. Coronary heart disease (CHD) risk [ Time Frame: Up to 10 years ]
    Change in estimated 10 year coronary heart disease (CHD) risk by the Framingham Risk Score (FRS), % (range, 0-100%)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All individuals, both children and adults, regardless of health status.

Inclusion Criteria:

  • Trials in humans
  • Randomized and non-randomized controlled trials
  • Assessment of the portfolio dietary pattern in comparison to caloric- and macronutrient-matched diets that were not intended to provide components of the portfolio dietary pattern
  • Diet duration ≥ 4 week
  • Viable outcome data with ≥ 1 outcome of interest

Exclusion Criteria:

  • Non-human trials
  • Observational studies
  • Lack of suitable comparator diet
  • Diet duration <4 weeks
  • No viable outcome data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03534414

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Canada, Ontario
The Toronto 3D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Micheal's Hospital
Toronto, Ontario, Canada, M5C 2T2
Sponsors and Collaborators
University of Toronto
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Principal Investigator: John Sievenpiper, MD, PhD University of Toronto

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Responsible Party: John Sievenpiper, Associate Professor, University of Toronto Identifier: NCT03534414    
Other Study ID Numbers: DNSG-Portfolio diet
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not applicable since there is no individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Sievenpiper, University of Toronto:
dietary portfolio
plant sterols
plant protein
viscous fibre
Additional relevant MeSH terms:
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Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipid Metabolism Disorders
Metabolic Diseases