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Trial record 1 of 1 for:    23595878 [PUBMED-IDS]
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Meta-analyses of Nuts and Risk of Obesity

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.
 
ClinicalTrials.gov Identifier: NCT02654535
Recruitment Status : Active, not recruiting
First Posted : January 13, 2016
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
John Sievenpiper, University of Toronto

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

Condition or disease Intervention/treatment
Body Weight Obesity Overweight Adiposity Obesity, Abdominal Other: Dietary tree nuts & peanuts

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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : October 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight


Intervention Details:
  • Other: Dietary tree nuts & peanuts
    An intervention in which tree nuts and/or peanuts are included in the diet
    Other Names:
    • almonds, pistachios, walnuts, pecans,
    • pine nuts, Brazil nuts, cashews,
    • hazelnuts, macadamia nuts, peanuts


Primary Outcome Measures :
  1. Incident overweight or obesity (prospective cohort studies) [ Time Frame: Up to 40 years ]
    Incident overweight or obesity

  2. Body weight (randomized controlled trials) [ Time Frame: Up to 40 years ]
    Body weight


Secondary Outcome Measures :
  1. Global measures of adiposity with established clinical relevance - body weight (prospective cohort studies) [ Time Frame: Up to 40 years ]
    Body weight

  2. Global measures of adiposity with established clinical relevance - BMI (prospective cohort studies and randomized controlled trials) [ Time Frame: Up to 40 years ]
    Body mass index (BMI)

  3. Global measures of adiposity with established clinical relevance - body fat (prospective cohort studies and randomized controlled trials) [ Time Frame: Up to 40 years ]
    Percentage body fat

  4. Regional measures of adiposity with established clinical relevance - waist circumference (prospective cohort studies and randomized controlled trials) [ Time Frame: Up to 40 years ]
    Waist circumference

  5. 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 ]
    Waist-to-hip ratio

  6. Regional measures of adiposity with established clinical relevance - visceral adipose tissue (prospective cohort studies and randomized controlled trials) [ Time Frame: Up to 40 years ]
    Visceral adipose tissue (VAT)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All adults (>=18 years), regardless of health status.
Criteria

Inclusion Criteria for randomized controlled trials:

  • 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

Inclusion Criteria for prospective cohort studies:

  • 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

Exclusion Criteria for randomized controlled trials:

  • 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

Exclusion Criteria for prospective cohort studies:

  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT02654535


Locations
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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. Michael's Hospital
Toronto, Ontario, Canada, M5C 2T2
Sponsors and Collaborators
John Sievenpiper
The Physicians' Services Incorporated Foundation
Investigators
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Principal Investigator: John L Sievenpiper, MD, PhD, FRCPC University of Toronto
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).
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.
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.

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Responsible Party: John Sievenpiper, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT02654535    
Other Study ID Numbers: INC-Nuts 2015
First Posted: January 13, 2016    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Keywords provided by John Sievenpiper, University of Toronto:
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
Additional relevant MeSH terms:
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Obesity
Obesity, Abdominal
Overweight
Body Weight
Overnutrition
Nutrition Disorders
Signs and Symptoms