Meta-analysis of the Portfolio Dietary Pattern and Cardiometabolic Risk

NCT03534414 | Unknown

• 1 other identifier: DNSG-Portfolio diet
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factor; Cholesterol; Lipidosis

Keywords

dietary portfolio; plant sterols; plant protein; viscous fibre; nuts

Outcome Measures

Primary Outcomes (1)

• Blood lipids - LDL-C

  Up to 20 years

Secondary Outcomes (13)

• Blood lipids - Total-C

  Up to 20 years

• Blood lipids - HDL-C

  Up to 20 years

• Blood lipids - non-HDL-C

  Up to 20 years

• Blood lipids - triglycerides

  Up to 20 years

• Blood lipids - Apolipoprotein B (apo B)

  Up to 20 years

Study Arms (2)

Intervention

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; Dietary Supplement: NCEP Based Diet

Control

A National Cholesterol Education Program (NCEP) based diet, a diet low in saturated fat and cholesterol.

Dietary Supplement: NCEP Based Diet

Interventions

Portfolio Dietary Pattern DIETARY_SUPPLEMENT

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)

Also known as: Dietary Portfolio, Portfolio Diet

Intervention

NCEP Based Diet DIETARY_SUPPLEMENT

A low saturated fat, low cholesterol diet.

Control; Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All individuals, both children and adults, regardless of health status.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

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, M5C 2T2, Canada

Location

Related Publications (5)

• Jenkins DJ, Kendall CW, Marchie A, Faulkner D, Vidgen E, Lapsley KG, Trautwein EA, Parker TL, Josse RG, Leiter LA, Connelly PW. The effect of combining plant sterols, soy protein, viscous fibers, and almonds in treating hypercholesterolemia. Metabolism. 2003 Nov;52(11):1478-83. doi: 10.1016/s0026-0495(03)00260-9.

  PMID: 14624410 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 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, 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 BACKGROUND

• Jenkins DJ, Chiavaroli L, Wong JM, Kendall C, Lewis GF, Vidgen E, Connelly PW, Leiter LA, Josse RG, Lamarche B. Adding monounsaturated fatty acids to a dietary portfolio of cholesterol-lowering foods in hypercholesterolemia. CMAJ. 2010 Dec 14;182(18):1961-7. doi: 10.1503/cmaj.092128. Epub 2010 Nov 1.

  PMID: 21041432 BACKGROUND

MeSH Terms

Conditions

Lipidoses

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• John Sievenpiper, MD, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 23, 2018
• Study Start: January 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: October 1, 2018
• Last Updated: May 23, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)