Meta-analyses of Nuts and Risk of Obesity

NCT02654535 | Completed

• 1 other identifier: INC-Nuts 2015
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Peanuts and tree nuts (almonds, pistachios, walnuts, pecans, pine nuts, Brazil nuts, cashews, hazelnuts, macadamia nuts) (herein referred to as "nuts") are a good source of unsaturated fatty acids, vegetable protein, fibre, and polyphenolics. Nut intake has been associated with reduced cardiovascular disease risk and claims for this association have been permitted by the FDA; however, intake of tree nuts is low in Canada. One of the barriers to increasing the consumption of nuts is the perception that they may contribute to weight gain more than other "healthy foods" owing to their high energy density. The evidence supporting this concern, however, is lacking. In a series of earlier systematic reviews and meta-analyses, we have shown that nuts improve glycemic control and metabolic syndrome criteria, findings which run contrary to any expected weight gain. However, it remains unclear whether nuts have an increasing, neutral, or even decreasing effect on body weight. To address the uncertainties, the investigators propose to conduct a series of systematic reviews and meta-analyses of the totality of the evidence from randomized controlled trials and prospective cohort studies to investigate the effect of nut consumption on body weight and adiposity. The findings generated by this proposed knowledge synthesis will help improve the health of consumers through informing evidence-based guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design

Conditions

Body Weight; Obesity; Overweight; Adiposity; Obesity, Abdominal

Keywords

Systematic review and meta-analysis; Evidence-based medicine (EBM); Evidence-based nutrition (EBN); Clinical practice guidelines; Clinical trials; Tree Nuts; Peanuts; Body weight; Prospective cohort studies

Outcome Measures

Primary Outcomes (2)

• Incident overweight or obesity (prospective cohort studies)

  Incident overweight or obesity

  Up to 40 years

• Body weight (randomized controlled trials)

  Body weight

  Up to 40 years

Secondary Outcomes (6)

• Global measures of adiposity with established clinical relevance - body weight (prospective cohort studies)

  Up to 40 years

• Global measures of adiposity with established clinical relevance - BMI (prospective cohort studies and randomized controlled trials)

  Up to 40 years

• Global measures of adiposity with established clinical relevance - body fat (prospective cohort studies and randomized controlled trials)

  Up to 40 years

• Regional measures of adiposity with established clinical relevance - waist circumference (prospective cohort studies and randomized controlled trials)

  Up to 40 years

• Regional measures of adiposity with established clinical relevance - waist-to-hip ratio (prospective cohort studies and randomized controlled trials)

  Up to 40 years

Interventions

Dietary tree nuts & peanuts OTHER

An intervention in which tree nuts and/or peanuts are included in the diet

Also known as: almonds, pistachios, walnuts, pecans,, pine nuts, Brazil nuts, cashews,, hazelnuts, macadamia nuts, peanuts

Eligibility Criteria

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

Study Population

All adults (\>=18 years), regardless of health status.

You may qualify if:

• Trials in adults (\>=18 years)
• Tree nut and/or peanut intervention
• Presence of an adequate comparator (substitution, addition, subtraction, or ad libitum control)
• Diet duration \>=3 weeks
• viable outcome data
• Prospective cohort studies or case-cohort studies
• Duration \>= 1 year
• Assessing adults (\>=18 years)
• Assessment of the exposure of tree nuts and/or peanuts
• Ascertainment of viable data by level of exposure

You may not qualify if:

• non-human trials
• assessing individuals \<18 years
• observational studies
• lack of suitable comparator diet (i.e. a comparator arm that contains substantial amounts of tree nuts or peanuts)
• Diet duration \<3-weeks
• No viable outcome data
• Ecological, cross-sectional, and retrospective observational studies, clinical trials, and non-human studies
• Duration \< 1 year
• assessing individuals \<18 years
• No assessment of exposures of tree nuts and/or peanuts
• No ascertainment viable clinical outcome data by level of exposure

Sponsors & Collaborators

• John Sievenpiper: lead
• The Physicians' Services Incorporated Foundation: 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 (27)

• U.S. Food and Drug Administration (FDA). Guidance for Industry: A Food Labeling Guide (12. Appendix D: Qualified Health Claims). Available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulartoyInformation/LabelingNutrition/ucm064923.htm (Page Last Updated: 08/20/2015).

  BACKGROUND

• Bao Y, Han J, Hu FB, Giovannucci EL, Stampfer MJ, Willett WC, Fuchs CS. Association of nut consumption with total and cause-specific mortality. N Engl J Med. 2013 Nov 21;369(21):2001-11. doi: 10.1056/NEJMoa1307352.

  PMID: 24256379 BACKGROUND

• Sabate J, Oda K, Ros E. Nut consumption and blood lipid levels: a pooled analysis of 25 intervention trials. Arch Intern Med. 2010 May 10;170(9):821-7. doi: 10.1001/archinternmed.2010.79.

  PMID: 20458092 BACKGROUND

• Public Health Agency of Canada (PHAC). National Single Day Food Consumption Report: Analysis of the 24-hour dietary recall data from the Canadian Community Health Survey (CCHS), Cycle 2.2, Nutrition (2004), and assessment for food consumption frequency among Canadians. Available at: http://www.phac-aspc.gc.ca.

  BACKGROUND

• Sievenpiper JL, Dworatzek PD. Food and dietary pattern-based recommendations: an emerging approach to clinical practice guidelines for nutrition therapy in diabetes. Can J Diabetes. 2013 Feb;37(1):51-7. doi: 10.1016/j.jcjd.2012.11.001. Epub 2013 Mar 14.

  PMID: 24070749 BACKGROUND

• Evert AB, Boucher JL, Cypress M, Dunbar SA, Franz MJ, Mayer-Davis EJ, Neumiller JJ, Nwankwo R, Verdi CL, Urbanski P, Yancy WS Jr. Nutrition therapy recommendations for the management of adults with diabetes. Diabetes Care. 2014 Jan;37 Suppl 1:S120-43. doi: 10.2337/dc14-S120. No abstract available.

  PMID: 24357208 BACKGROUND

• Anderson TJ, Gregoire J, Hegele RA, Couture P, Mancini GB, McPherson R, Francis GA, Poirier P, Lau DC, Grover S, Genest J Jr, Carpentier AC, Dufour R, Gupta M, Ward R, Leiter LA, Lonn E, Ng DS, Pearson GJ, Yates GM, Stone JA, Ur E. 2012 update of the Canadian Cardiovascular Society guidelines for the diagnosis and treatment of dyslipidemia for the prevention of cardiovascular disease in the adult. Can J Cardiol. 2013 Feb;29(2):151-67. doi: 10.1016/j.cjca.2012.11.032.

  PMID: 23351925 BACKGROUND

• Viguiliouk E, Kendall CW, Blanco Mejia S, Cozma AI, Ha V, Mirrahimi A, Jayalath VH, Augustin LS, Chiavaroli L, Leiter LA, de Souza RJ, Jenkins DJ, Sievenpiper JL. Effect of tree nuts on glycemic control in diabetes: a systematic review and meta-analysis of randomized controlled dietary trials. PLoS One. 2014 Jul 30;9(7):e103376. doi: 10.1371/journal.pone.0103376. eCollection 2014.

  PMID: 25076495 BACKGROUND

• Blanco Mejia S, Kendall CW, Viguiliouk E, Augustin LS, Ha V, Cozma AI, Mirrahimi A, Maroleanu A, Chiavaroli L, Leiter LA, de Souza RJ, Jenkins DJ, Sievenpiper JL. Effect of tree nuts on metabolic syndrome criteria: a systematic review and meta-analysis of randomised controlled trials. BMJ Open. 2014 Jul 29;4(7):e004660. doi: 10.1136/bmjopen-2013-004660.

  PMID: 25074070 BACKGROUND

• Higgins JPT, Greens S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.

  BACKGROUND

• Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009 Jul 21;339:b2535. doi: 10.1136/bmj.b2535.

  PMID: 19622551 BACKGROUND

• Guyatt GH, Oxman AD, Schunemann HJ, Tugwell P, Knottnerus A. GRADE guidelines: a new series of articles in the Journal of Clinical Epidemiology. J Clin Epidemiol. 2011 Apr;64(4):380-2. doi: 10.1016/j.jclinepi.2010.09.011. Epub 2010 Dec 24.

  PMID: 21185693 BACKGROUND

• Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, Norris S, Falck-Ytter Y, Glasziou P, DeBeer H, Jaeschke R, Rind D, Meerpohl J, Dahm P, Schunemann HJ. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011 Apr;64(4):383-94. doi: 10.1016/j.jclinepi.2010.04.026. Epub 2010 Dec 31.

  PMID: 21195583 BACKGROUND

• Guyatt GH, Oxman AD, Kunz R, Atkins D, Brozek J, Vist G, Alderson P, Glasziou P, Falck-Ytter Y, Schunemann HJ. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011 Apr;64(4):395-400. doi: 10.1016/j.jclinepi.2010.09.012. Epub 2010 Dec 30.

  PMID: 21194891 BACKGROUND

• Balshem H, Helfand M, Schunemann HJ, Oxman AD, Kunz R, Brozek J, Vist GE, Falck-Ytter Y, Meerpohl J, Norris S, Guyatt GH. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol. 2011 Apr;64(4):401-6. doi: 10.1016/j.jclinepi.2010.07.015. Epub 2011 Jan 5.

  PMID: 21208779 BACKGROUND

• Guyatt GH, Oxman AD, Vist G, Kunz R, Brozek J, Alonso-Coello P, Montori V, Akl EA, Djulbegovic B, Falck-Ytter Y, Norris SL, Williams JW Jr, Atkins D, Meerpohl J, Schunemann HJ. GRADE guidelines: 4. Rating the quality of evidence--study limitations (risk of bias). J Clin Epidemiol. 2011 Apr;64(4):407-15. doi: 10.1016/j.jclinepi.2010.07.017. Epub 2011 Jan 19.

  PMID: 21247734 BACKGROUND

• Guyatt GH, Oxman AD, Montori V, Vist G, Kunz R, Brozek J, Alonso-Coello P, Djulbegovic B, Atkins D, Falck-Ytter Y, Williams JW Jr, Meerpohl J, Norris SL, Akl EA, Schunemann HJ. GRADE guidelines: 5. Rating the quality of evidence--publication bias. J Clin Epidemiol. 2011 Dec;64(12):1277-82. doi: 10.1016/j.jclinepi.2011.01.011. Epub 2011 Jul 30.

  PMID: 21802904 BACKGROUND

• Guyatt GH, Oxman AD, Kunz R, Brozek J, Alonso-Coello P, Rind D, Devereaux PJ, Montori VM, Freyschuss B, Vist G, Jaeschke R, Williams JW Jr, Murad MH, Sinclair D, Falck-Ytter Y, Meerpohl J, Whittington C, Thorlund K, Andrews J, Schunemann HJ. GRADE guidelines 6. Rating the quality of evidence--imprecision. J Clin Epidemiol. 2011 Dec;64(12):1283-93. doi: 10.1016/j.jclinepi.2011.01.012. Epub 2011 Aug 11.

  PMID: 21839614 BACKGROUND

• Guyatt GH, Oxman AD, Kunz R, Woodcock J, Brozek J, Helfand M, Alonso-Coello P, Glasziou P, Jaeschke R, Akl EA, Norris S, Vist G, Dahm P, Shukla VK, Higgins J, Falck-Ytter Y, Schunemann HJ; GRADE Working Group. GRADE guidelines: 7. Rating the quality of evidence--inconsistency. J Clin Epidemiol. 2011 Dec;64(12):1294-302. doi: 10.1016/j.jclinepi.2011.03.017. Epub 2011 Jul 31.

  PMID: 21803546 BACKGROUND

• Guyatt GH, Oxman AD, Kunz R, Woodcock J, Brozek J, Helfand M, Alonso-Coello P, Falck-Ytter Y, Jaeschke R, Vist G, Akl EA, Post PN, Norris S, Meerpohl J, Shukla VK, Nasser M, Schunemann HJ; GRADE Working Group. GRADE guidelines: 8. Rating the quality of evidence--indirectness. J Clin Epidemiol. 2011 Dec;64(12):1303-10. doi: 10.1016/j.jclinepi.2011.04.014. Epub 2011 Jul 30.

  PMID: 21802903 BACKGROUND

• Guyatt GH, Oxman AD, Sultan S, Glasziou P, Akl EA, Alonso-Coello P, Atkins D, Kunz R, Brozek J, Montori V, Jaeschke R, Rind D, Dahm P, Meerpohl J, Vist G, Berliner E, Norris S, Falck-Ytter Y, Murad MH, Schunemann HJ; GRADE Working Group. GRADE guidelines: 9. Rating up the quality of evidence. J Clin Epidemiol. 2011 Dec;64(12):1311-6. doi: 10.1016/j.jclinepi.2011.06.004. Epub 2011 Jul 30.

  PMID: 21802902 BACKGROUND

• Brunetti M, Shemilt I, Pregno S, Vale L, Oxman AD, Lord J, Sisk J, Ruiz F, Hill S, Guyatt GH, Jaeschke R, Helfand M, Harbour R, Davoli M, Amato L, Liberati A, Schunemann HJ. GRADE guidelines: 10. Considering resource use and rating the quality of economic evidence. J Clin Epidemiol. 2013 Feb;66(2):140-50. doi: 10.1016/j.jclinepi.2012.04.012. Epub 2012 Aug 3.

  PMID: 22863410 BACKGROUND

• Guyatt G, Oxman AD, Sultan S, Brozek J, Glasziou P, Alonso-Coello P, Atkins D, Kunz R, Montori V, Jaeschke R, Rind D, Dahm P, Akl EA, Meerpohl J, Vist G, Berliner E, Norris S, Falck-Ytter Y, Schunemann HJ. GRADE guidelines: 11. Making an overall rating of confidence in effect estimates for a single outcome and for all outcomes. J Clin Epidemiol. 2013 Feb;66(2):151-7. doi: 10.1016/j.jclinepi.2012.01.006. Epub 2012 Apr 27.

  PMID: 22542023 BACKGROUND

• Guyatt GH, Oxman AD, Santesso N, Helfand M, Vist G, Kunz R, Brozek J, Norris S, Meerpohl J, Djulbegovic B, Alonso-Coello P, Post PN, Busse JW, Glasziou P, Christensen R, Schunemann HJ. GRADE guidelines: 12. Preparing summary of findings tables-binary outcomes. J Clin Epidemiol. 2013 Feb;66(2):158-72. doi: 10.1016/j.jclinepi.2012.01.012. Epub 2012 May 18.

  PMID: 22609141 BACKGROUND

• Guyatt GH, Thorlund K, Oxman AD, Walter SD, Patrick D, Furukawa TA, Johnston BC, Karanicolas P, Akl EA, Vist G, Kunz R, Brozek J, Kupper LL, Martin SL, Meerpohl JJ, Alonso-Coello P, Christensen R, Schunemann HJ. GRADE guidelines: 13. Preparing summary of findings tables and evidence profiles-continuous outcomes. J Clin Epidemiol. 2013 Feb;66(2):173-83. doi: 10.1016/j.jclinepi.2012.08.001. Epub 2012 Oct 30.

  PMID: 23116689 BACKGROUND

• Flores-Mateo G, Rojas-Rueda D, Basora J, Ros E, Salas-Salvado J. Nut intake and adiposity: meta-analysis of clinical trials. Am J Clin Nutr. 2013 Jun;97(6):1346-55. doi: 10.3945/ajcn.111.031484. Epub 2013 Apr 17.

  PMID: 23595878 BACKGROUND

• Nishi SK, Viguiliouk E, Blanco Mejia S, Kendall CWC, Bazinet RP, Hanley AJ, Comelli EM, Salas Salvado J, Jenkins DJA, Sievenpiper JL. Are fatty nuts a weighty concern? A systematic review and meta-analysis and dose-response meta-regression of prospective cohorts and randomized controlled trials. Obes Rev. 2021 Nov;22(11):e13330. doi: 10.1111/obr.13330. Epub 2021 Sep 8.

  PMID: 34494363 RESULT

Related Links

• Open Access Publication of the Registered Study: Are fatty nuts a weighty concern? A systematic review and meta-analysis and dose-response meta-regression of prospective cohorts and randomized controlled trials

MeSH Terms

Conditions

Body Weight; Obesity; Overweight; Obesity, Abdominal

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• John L Sievenpiper, MD, PhD, FRCPC

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 13, 2016
• Study Start: October 1, 2015
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

CA (1)