Umbrella Review and Updated Systematic Review and Meta-analysis of Pulses/Legumes and Incident Cardiometabolic Diseases

NCT03555734 | Unknown

• 1 other identifier: DNSG-Pulses
• 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 dietary pulses. To update the recommendations, the Diabetes and Nutrition Study Group (DNSG) of the EASD commissioned an umbrella review and updated systematic review and meta-analysis using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to summarize the available evidence from prospective cohort studies of the association between dietary pulses/legumes and cardiometabolic disease outcomes (incident cardiovascular diseases, diabetes, hypertension and overweight/obesity).

Conditions

Cardiovascular Diseases; Coronary Heart Disease; Stroke; Diabetes Mellitus, Type 2; Hypertension; Obesity

Keywords

Pulses (beans, chickpeas, lentils, dry peas); Legumes; Cardiovascular disease; Coronary heart disease; Stroke; Diabetes; Hypertension; Obesity; Prospective cohort studies; Umbrella review; Systematic review and meta-analysis

Outcome Measures

Primary Outcomes (1)

• Cardiovascular disease (CVD)

  Risk ratios for CVD incidence and mortality

  Up to 20 years

Secondary Outcomes (5)

• Coronary heat disease (CHD)

  Up to 20 years

• Stroke

  Up to 20 years

• Diabetes

  Up to 20 years

• Hypertension

  Up to 20 years

• Obesity

  Up to 20 years

Interventions

Dietary pulses or legumes OTHER

Dietary pulses (dried beans, dried peas, chickpeas, lentils). If no data available specifically for dietary pulses than legumes will be assessed as the exposure (includes pulses, soybeans, peanuts, fresh peas, fresh beans).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers or those at risk for cardiometabolic diseases

You may qualify if:

• Umbrella review:
• Systematic reviews and meta-analyses of prospective cohort studies assessing the relationship of dietary pulses or legumes with incident cardiometabolic diseases (cardiovascular diseases, diabetes, and hypertension).
• Updated systematic review and meta-analysis:
• Prospective cohorts studies
• Follow-up duration \>=1 year
• Assessment of the exposure of pulses or legumes
• Ascertainment of viable data by level of exposure (cardiovascular diseases, diabetes, and hypertension).

You may not qualify if:

• Umbrella review:
• Not a systematic review and meta-analysis of prospective cohort studies that assess' the relationship of dietary pulses or legumes with incident cardiometabolic diseases
• Updated systematic review and meta-analysis:
• Ecological, cross-sectional, retrospective observational studies, clinical trials and non-human studies
• Duration \<1 year
• No assessment of the exposure of pulses or legumes
• No ascertainment of viable data by level of exposure

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• European Foundation for the Study of Diabetes: collaborator

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. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (13)

• Mitchell DC, Lawrence FR, Hartman TJ, Curran JM. Consumption of dry beans, peas, and lentils could improve diet quality in the US population. J Am Diet Assoc. 2009 May;109(5):909-13. doi: 10.1016/j.jada.2009.02.029.

  PMID: 19394480 BACKGROUND

• Mudryj AN, Yu N, Hartman TJ, Mitchell DC, Lawrence FR, Aukema HM. Pulse consumption in Canadian adults influences nutrient intakes. Br J Nutr. 2012 Aug;108 Suppl 1:S27-36. doi: 10.1017/S0007114512000724.

  PMID: 22916812 BACKGROUND

• Ha V, Sievenpiper JL, de Souza RJ, Jayalath VH, Mirrahimi A, Agarwal A, Chiavaroli L, Mejia SB, Sacks FM, Di Buono M, Bernstein AM, Leiter LA, Kris-Etherton PM, Vuksan V, Bazinet RP, Josse RG, Beyene J, Kendall CW, Jenkins DJ. Effect of dietary pulse intake on established therapeutic lipid targets for cardiovascular risk reduction: a systematic review and meta-analysis of randomized controlled trials. CMAJ. 2014 May 13;186(8):E252-62. doi: 10.1503/cmaj.131727. Epub 2014 Apr 7.

  PMID: 24710915 BACKGROUND

• Jayalath VH, de Souza RJ, Sievenpiper JL, Ha V, Chiavaroli L, Mirrahimi A, Di Buono M, Bernstein AM, Leiter LA, Kris-Etherton PM, Vuksan V, Beyene J, Kendall CW, Jenkins DJ. Effect of dietary pulses on blood pressure: a systematic review and meta-analysis of controlled feeding trials. Am J Hypertens. 2014 Jan;27(1):56-64. doi: 10.1093/ajh/hpt155. Epub 2013 Sep 7.

  PMID: 24014659 BACKGROUND

• Kim SJ, de Souza RJ, Choo VL, Ha V, Cozma AI, Chiavaroli L, Mirrahimi A, Blanco Mejia S, Di Buono M, Bernstein AM, Leiter LA, Kris-Etherton PM, Vuksan V, Beyene J, Kendall CW, Jenkins DJ, Sievenpiper JL. Effects of dietary pulse consumption on body weight: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2016 May;103(5):1213-23. doi: 10.3945/ajcn.115.124677. Epub 2016 Mar 30.

  PMID: 27030531 BACKGROUND

• Li SS, Kendall CW, de Souza RJ, Jayalath VH, Cozma AI, Ha V, Mirrahimi A, Chiavaroli L, Augustin LS, Blanco Mejia S, Leiter LA, Beyene J, Jenkins DJ, Sievenpiper JL. Dietary pulses, satiety and food intake: a systematic review and meta-analysis of acute feeding trials. Obesity (Silver Spring). 2014 Aug;22(8):1773-80. doi: 10.1002/oby.20782. Epub 2014 May 13.

  PMID: 24820437 BACKGROUND

• Sievenpiper JL, Kendall CW, Esfahani A, Wong JM, Carleton AJ, Jiang HY, Bazinet RP, Vidgen E, Jenkins DJ. Effect of non-oil-seed pulses on glycaemic control: a systematic review and meta-analysis of randomised controlled experimental trials in people with and without diabetes. Diabetologia. 2009 Aug;52(8):1479-95. doi: 10.1007/s00125-009-1395-7. Epub 2009 Jun 13.

  PMID: 19526214 BACKGROUND

• Mann JI, De Leeuw I, Hermansen K, Karamanos B, Karlstrom B, Katsilambros N, Riccardi G, Rivellese AA, Rizkalla S, Slama G, Toeller M, Uusitupa M, Vessby B; Diabetes and Nutrition Study Group (DNSG) of the European Association. Evidence-based nutritional approaches to the treatment and prevention of diabetes mellitus. Nutr Metab Cardiovasc Dis. 2004 Dec;14(6):373-94. doi: 10.1016/s0939-4753(04)80028-0. No abstract available.

  PMID: 15853122 BACKGROUND

• Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23. No abstract available.

  PMID: 27222591 BACKGROUND

• Anderson TJ, Gregoire J, Pearson GJ, Barry AR, Couture P, Dawes M, Francis GA, Genest J Jr, Grover S, Gupta M, Hegele RA, Lau DC, Leiter LA, Lonn E, Mancini GB, McPherson R, Ngui D, Poirier P, Sievenpiper JL, Stone JA, Thanassoulis G, Ward R. 2016 Canadian Cardiovascular Society Guidelines for the Management of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult. Can J Cardiol. 2016 Nov;32(11):1263-1282. doi: 10.1016/j.cjca.2016.07.510. Epub 2016 Jul 25.

  PMID: 27712954 BACKGROUND

• Diabetes Canada Clinical Practice Guidelines Expert Committee; Sievenpiper JL, Chan CB, Dworatzek PD, Freeze C, Williams SL. Nutrition Therapy. Can J Diabetes. 2018 Apr;42 Suppl 1:S64-S79. doi: 10.1016/j.jcjd.2017.10.009. No abstract available.

  PMID: 29650114 BACKGROUND

• American Diabetes Association. 4. Lifestyle Management: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S38-S50. doi: 10.2337/dc18-S004.

  PMID: 29222375 BACKGROUND

• Viguiliouk E, Glenn AJ, Nishi SK, Chiavaroli L, Seider M, Khan T, Bonaccio M, Iacoviello L, Mejia SB, Jenkins DJA, Kendall CWC, Kahleova H, Rahelic D, Salas-Salvado J, Sievenpiper JL. Associations between Dietary Pulses Alone or with Other Legumes and Cardiometabolic Disease Outcomes: An Umbrella Review and Updated Systematic Review and Meta-analysis of Prospective Cohort Studies. Adv Nutr. 2019 Nov 1;10(Suppl_4):S308-S319. doi: 10.1093/advances/nmz113.

  PMID: 31728500 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Disease; Stroke; Diabetes Mellitus, Type 2; Hypertension; Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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, MD, PhD, FRCPC

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 13, 2018
• Study Start: November 21, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: June 13, 2018

Record last verified: 2018-06

Locations

CA (1)