Body WeightNCT02654535
Meta-analyses of Nuts and Risk of Obesity
An observational study of Body Weight and Obesity, run by John Sievenpiper at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Body Weight, Obesity, Overweight
- What is being tested?
- Dietary tree nuts & peanuts
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All adults (>=18 years), regardless of health status.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
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
About this study
Official title: Nuts in Relation to Markers of Adiposity, Overweight, and Obesity: A Series of Systematic Reviews and Meta-analyses of Randomized Controlled Trials and Prospective Cohort Studies
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
Read the detailed description
Background: Peanuts and tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios and walnuts) are an important source of unsaturated fatty acids, vegetable protein, and fibre, as well as minerals, vitamins, and phytonutrients. The FDA has permitted health claims for tree nuts for cardiovascular disease risk reduction and the cardiovascular benefits of nuts is acknowledged [FDA, 2015; Bao et al., 2013; Sabate et al., 2010]; however, intake of tree nuts is low in Canada. Based on the 2004 Canadian Community Health Survey (CCHS), <5% of Canadians consumed nuts on any given day with a mean intake of 18 g/day in those consuming nuts [PHAC, 2004]. This intake level is far below the 42 g/day amount recommended by the FDA for cardiovascular risk reduction. 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. With the rise in overweight and obesity and its downstream cardiometabolic complications, heart and diabetes associations have cautioned against the over consumption of nuts at the same time that they recommend them for heart health [Sievenpiper et al., 2013; Evert et al., 2014; Anderson et al., 2013]. 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 [Viguiliouk et al., 2014; Blanco Mejia et al., 2014]. Although an earlier systematic review and meta-analysis of controlled trials showed a lack of effect of nut intake on body weight [Flores-Mateo et al., 2013], it remains unclear whether nuts have an increasing, neutral, or even decreasing effect on a broader set of markers of adiposity.
Need for proposed research:The lack of high quality syntheses and knowledge translation to reconcile the benefits of nuts with potential weight gain represents an urgent call for stronger evidence. High quality systematic reviews and meta-analyses of randomized controlled trials and prospective cohort studies represent the highest level of evidence to support dietary guidelines and public health policy development.
Objective: The investigators will conduct a series of systematic reviews and meta-analyses to (1) distinguish the effect of peanuts and tree nuts on body weight and markers of adiposity in randomized controlled trials and (2) assess peanut and tree nut consumption with incident overweight/obesity and changes in weight and markers of adiposity in prospective cohort studies.
Design: Each systematic review and meta-analysis will be conducted according to the Cochrane Handbook for Systematic Reviews of Interventions and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) [Higgins et al., 2011; Moher et al., 2009].
Data sources: MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (Clinical Trials; CENTRAL) will be searched using appropriate search terms supplemented by hand searches of references of included studies.
Study selection: The investigators will include either randomized controlled dietary trials or prospective cohort studies. Randomized controlled trials that investigate the effect of including and/or exchanging nuts for other nutrients on changes in body weight or markers of adiposity outcomes in adults (>= 18 years) will be included. Studies that are <3-weeks diet duration, lack a control, include individuals <18 years, or assess intake during wasting conditions/malnourished populations, pregnancy or lactation will be excluded. Prospective cohort studies will be included if they are >= 1-year duration, involving adults (>=18 years) and assess the relation of tree nuts and/or peanuts with incident overweight/obesity or changes in body weight or markers of adiposity.
Data extraction: Two or more investigators will independently extract relevant data and assess risk of bias using the Cochrane Risk of Bias Tool. All disagreements will be resolved by consensus. Standard computations and imputations will be used to derive missing variance data.
Outcomes: Three sets of outcomes will be assessed: (1) incidence of overweight/obesity, (2) measures of global adiposity (body weight, body mass index (BMI), body fat), (3) measures of abdominal adiposity (waist circumference, waist-to-hip ratio, visceral adipose tissue).
Data synthesis: Mean differences will be pooled for the trials and risk ratios for the cohorts using the generic inverse variance method. Random-effects models will be used even in the absence of statistically significant between-study heterogeneity, as they yield more conservative summary effect estimates in the presence of residual heterogeneity. Fixed-effects models will only be used where there is <5 included studies. Paired analyses will be applied for crossover trials. Heterogeneity will be assessed by the Cochran Q statistic and quantified by the I2 statistic. To explore sources of heterogeneity, the investigators will conduct sensitivity analyses, in which each study is systematically removed. If there are >=10 studies, then the investigators will also explore sources of heterogeneity by a priori subgroup analyses by health status (metabolic syndrome/diabetes, overweight, normal weight), comparator (carbohydrate, other fat source, animal protein, mixed macronutrient, other), nut type, nut dose, baseline measurements, randomization, study design (parallel, crossover), energy balance (positive, neutral, negative), duration of follow-up, and risk of bias. Meta-regression analyses will assess the significance of categorical and continuous subgroups analyses. When >=10 studies are available, publication bias will be investigated by inspection of funnel plots and formal testing using the Egger and Begg tests. If publication bias is suspected, then the investigators will attempt to adjust for funnel plot asymmetry by imputing the missing study data using the Duval and Tweedie trim and fill method.
Evidence Assessment: The strength of the evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) [Guyatt et al., 2011a, 2011b, 2011c, 2011d, 2011e, 2011f, 2011g, 2011h, 2011i; Balshem et al., 2011; Brunetti et al., 2013; Guyatt et al., 2013a, 2013b, 2013c].
Knowledge translation plan: The results will be disseminated through interactive presentations at local, national, and international scientific meetings and publication in high impact factor journals. Target audiences will include the public health and scientific communities with interest in nutrition, diabetes, obesity, and cardiovascular disease. Feedback will be incorporated and used to improve the public health message and key areas for future research will be defined. Applicant/Co-applicant Decision Makers will network among opinion leaders to increase awareness and participate directly as committee members in the development of future guidelines.
Significance: The proposed project will aid in knowledge translation related to the role of peanuts and tree nuts in relation to body weight, in particular adiposity and the development of overweight and obesity, strengthening the evidence-base for 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
- Being tested
- Dietary tree nuts & peanuts
- 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
- Medical subject headings
- Body Weight, Obesity, Overweight, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary tree nuts & peanutsOther
Also called almonds, pistachios, walnuts, pecans,, pine nuts, Brazil nuts, cashews,, hazelnuts, macadamia nuts, peanuts
An intervention in which tree nuts and/or peanuts are included in the diet
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident overweight or obesity (prospective cohort studies)
Incident overweight or obesity
Measured: Up to 40 years
Body weight (randomized controlled trials)
Body weight
Measured: Up to 40 years
Secondary outcomes (6)
Global measures of adiposity with established clinical relevance - body weight (prospective cohort studies)
Body weight
Measured: Up to 40 years
Global measures of adiposity with established clinical relevance - BMI (prospective cohort studies and randomized controlled trials)
Body mass index (BMI)
Measured: Up to 40 years
Global measures of adiposity with established clinical relevance - body fat (prospective cohort studies and randomized controlled trials)
Percentage body fat
Measured: Up to 40 years
Regional measures of adiposity with established clinical relevance - waist circumference (prospective cohort studies and randomized controlled trials)
Waist circumference
Measured: Up to 40 years
Regional measures of adiposity with established clinical relevance - waist-to-hip ratio (prospective cohort studies and randomized controlled trials)
Waist-to-hip ratio
Measured: Up to 40 years
Regional measures of adiposity with established clinical relevance - visceral adipose tissue (prospective cohort studies and randomized controlled trials)
Visceral adipose tissue (VAT)
Measured: Up to 40 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startOct 2015
- Primary completionSep 2021
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Sievenpiper
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor-investigator, John Sievenpiper, University of Toronto
- Investigators
- John L Sievenpiper, MD, PhD, FRCPC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654535
- Sponsor's protocol ID
- INC-Nuts 2015
- Status last verified
- Oct 2021
- First submitted
- 11 Jan 2016
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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).
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.
PubMed 24256379Sabate 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.
PubMed 20458092Public 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.
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.
PubMed 24070749Evert 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.
PubMed 24357208Anderson 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.
PubMed 23351925Viguiliouk 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.
PubMed 25076495Blanco 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.
PubMed 25074070Higgins 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.
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.
PubMed 19622551Guyatt 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.
PubMed 21185693Guyatt 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.
PubMed 21195583Guyatt 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.
PubMed 21194891Balshem 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.
PubMed 21208779
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nuts in Relation to Markers of Adiposity, Overweight, and Obesity: A Series of Systematic Reviews and Meta-analyses of Randomized Controlled Trials and Prospective Cohort Studies
- ClinicalTrials.gov ID
- NCT02654535
- Acronym / sponsor ID
- INC-Nuts 2015
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- John SievenpiperUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Oct 2015 (actual)
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Background: Peanuts and tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios and walnuts) are an important source of unsaturated fatty acids, vegetable protein, and fibre, as well as minerals, vitamins, and phytonutrients. The FDA has permitted health claims for tree nuts for cardiovascular disease risk reduction and the cardiovascular benefits of nuts is acknowledged [FDA, 2015; Bao et al., 2013; Sabate et al., 2010]; however, intake of tree nuts is low in Canada. Based on the 2004 Canadian Community Health Survey (CCHS), <5% of Canadians consumed nuts on any given day with a mean intake of 18 g/day in those consuming nuts [PHAC, 2004]. This intake level is far below the 42 g/day amount recommended by the FDA for cardiovascular risk reduction. 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. With the rise in overweight and obesity and its downstream cardiometabolic complications, heart and diabetes associations have cautioned against the over consumption of nuts at the same time that they recommend them for heart health [Sievenpiper et al., 2013; Evert et al., 2014; Anderson et al., 2013]. 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 [Viguiliouk et al., 2014; Blanco Mejia et al., 2014]. Although an earlier systematic review and meta-analysis of controlled trials showed a lack of effect of nut intake on body weight [Flores-Mateo et al., 2013], it remains unclear whether nuts have an increasing, neutral, or even decreasing effect on a broader set of markers of adiposity.
Need for proposed research:The lack of high quality syntheses and knowledge translation to reconcile the benefits of nuts with potential weight gain represents an urgent call for stronger evidence. High quality systematic reviews and meta-analyses of randomized controlled trials and prospective cohort studies represent the highest level of evidence to support dietary guidelines and public health policy development.
Objective: The investigators will conduct a series of systematic reviews and meta-analyses to (1) distinguish the effect of peanuts and tree nuts on body weight and markers of adiposity in randomized controlled trials and (2) assess peanut and tree nut consumption with incident overweight/obesity and changes in weight and markers of adiposity in prospective cohort studies.
Design: Each systematic review and meta-analysis will be conducted according to the Cochrane Handbook for Systematic Reviews of Interventions and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) [Higgins et al., 2011; Moher et al., 2009].
Data sources: MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (Clinical Trials; CENTRAL) will be searched using appropriate search terms supplemented by hand searches of references of included studies.
Study selection: The investigators will include either randomized controlled dietary trials or prospective cohort studies. Randomized controlled trials that investigate the effect of including and/or exchanging nuts for other nutrients on changes in body weight or markers of adiposity outcomes in adults (>= 18 years) will be included. Studies that are <3-weeks diet duration, lack a control, include individuals <18 years, or assess intake during wasting conditions/malnourished populations, pregnancy or lactation will be excluded. Prospective cohort studies will be included if they are >= 1-year duration, involving adults (>=18 years) and assess the relation of tree nuts and/or peanuts with incident overweight/obesity or changes in body weight or markers of adiposity.
Data extraction: Two or more investigators will independently extract relevant data and assess risk of bias using the Cochrane Risk of Bias Tool. All disagreements will be resolved by consensus. Standard computations and imputations will be used to derive missing variance data.
Outcomes: Three sets of outcomes will be assessed: (1) incidence of overweight/obesity, (2) measures of global adiposity (body weight, body mass index (BMI), body fat), (3) measures of abdominal adiposity (waist circumference, waist-to-hip ratio, visceral adipose tissue).
Data synthesis: Mean differences will be pooled for the trials and risk ratios for the cohorts using the generic inverse variance method. Random-effects models will be used even in the absence of statistically significant between-study heterogeneity, as they yield more conservative summary effect estimates in the presence of residual heterogeneity. Fixed-effects models will only be used where there is <5 included studies. Paired analyses will be applied for crossover trials. Heterogeneity will be assessed by the Cochran Q statistic and quantified by the I2 statistic. To explore sources of heterogeneity, the investigators will conduct sensitivity analyses, in which each study is systematically removed. If there are >=10 studies, then the investigators will also explore sources of heterogeneity by a priori subgroup analyses by health status (metabolic syndrome/diabetes, overweight, normal weight), comparator (carbohydrate, other fat source, animal protein, mixed macronutrient, other), nut type, nut dose, baseline measurements, randomization, study design (parallel, crossover), energy balance (positive, neutral, negative), duration of follow-up, and risk of bias. Meta-regression analyses will assess the significance of categorical and continuous subgroups analyses. When >=10 studies are available, publication bias will be investigated by inspection of funnel plots and formal testing using the Egger and Begg tests. If publication bias is suspected, then the investigators will attempt to adjust for funnel plot asymmetry by imputing the missing study data using the Duval and Tweedie trim and fill method.
Evidence Assessment: The strength of the evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) [Guyatt et al., 2011a, 2011b, 2011c, 2011d, 2011e, 2011f, 2011g, 2011h, 2011i; Balshem et al., 2011; Brunetti et al., 2013; Guyatt et al., 2013a, 2013b, 2013c].
Knowledge translation plan: The results will be disseminated through interactive presentations at local, national, and international scientific meetings and publication in high impact factor journals. Target audiences will include the public health and scientific communities with interest in nutrition, diabetes, obesity, and cardiovascular disease. Feedback will be incorporated and used to improve the public health message and key areas for future research will be defined. Applicant/Co-applicant Decision Makers will network among opinion leaders to increase awareness and participate directly as committee members in the development of future guidelines.
Significance: The proposed project will aid in knowledge translation related to the role of peanuts and tree nuts in relation to body weight, in particular adiposity and the development of overweight and obesity, strengthening the evidence-base for guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adults (>=18 years), regardless of health status.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary tree nuts & peanutsAlso: almonds, pistachios, walnuts, pecans,, pine nuts, Brazil nuts, cashews,, hazelnuts, macadamia nuts, peanutsAn intervention in which tree nuts and/or peanuts are included in the diet | Other | – |
Primary outcome
Incident overweight or obesity (prospective cohort studies)
Time frame: Up to 40 years
Incident overweight or obesity
Body weight (randomized controlled trials)
Time frame: Up to 40 years
Body weight
6 secondary outcomes
Global measures of adiposity with established clinical relevance - body weight (prospective cohort studies)
Time frame: Up to 40 years
Global measures of adiposity with established clinical relevance - BMI (prospective cohort studies and randomized controlled trials)
Time frame: Up to 40 years
Global measures of adiposity with established clinical relevance - body fat (prospective cohort studies and randomized controlled trials)
Time frame: Up to 40 years
Regional measures of adiposity with established clinical relevance - waist circumference (prospective cohort studies and randomized controlled trials)
Time frame: Up to 40 years
Regional measures of adiposity with established clinical relevance - waist-to-hip ratio (prospective cohort studies and randomized controlled trials)
Time frame: Up to 40 years
Regional measures of adiposity with established clinical relevance - visceral adipose tissue (prospective cohort studies and randomized controlled trials)
Time frame: Up to 40 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- BackgroundU.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: PubMed 24256379Bao 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.
- Background: PubMed 20458092Sabate 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.
- BackgroundPublic 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: PubMed 24070749Sievenpiper 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John L Sievenpiper, MD, PhD, FRCPC principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Weight and Obesity, run by John Sievenpiper at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident overweight or obesity (prospective cohort studies) (time frame: Up to 40 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02654535, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.