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Meta-analyses of Pasta as Part of Low Glycemic Index Diets and Adiposity

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ClinicalTrials.gov Identifier: NCT02961088
Recruitment Status : Active, not recruiting
First Posted : November 10, 2016
Last Update Posted : November 17, 2016
Sponsor:
Collaborator:
Toronto 3D Knowledge Synthesis and Clinical Trials foundation
Information provided by (Responsible Party):
John Sievenpiper, University of Toronto

Brief Summary:
Pasta is an important example of a food which can lower the glycemic index (GI) of the diet, a property that has been exploited extensively in studies of low GI dietary patterns. Although low-GI dietary patterns have been shown to improve body weight, glycemic control and blood lipids, it is unclear whether pasta as part of low-GI dietary patterns will improve measures of global adiposity including body weight. The lack of high quality knowledge syntheses to support evidence-based dietary guidance of the cardiometabolic benefits of pasta represents an urgent call for stronger evidence. To improve evidence-based guidance for pasta recommendations, the investigators propose to conduct a systematic review and meta-analysis of controlled studies in humans to assess the effect of eating pasta as part of a low GI diet compared to other diets on measures of adiposity (body fatness) in humans. The systematic review process allows the combining of the results from many studies in order to arrive at a pooled estimate, similar to a weighted average, of the true effect. The investigators will be able to explore whether eating pasta as part of a low GI diet has different effects between men and women, in different age groups and in people with high or normal sugar. The findings of this proposed knowledge synthesis will help improve the health of Canadians through informing recommendations for the general public, as well as those at risk of heart disease and diabetes.

Condition or disease Intervention/treatment
Diabetes Prediabetes Overweight Obesity Metabolic Syndrome Cardiovascular Disease Other: Pasta as part of a low GI/GL diet

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 1 participants
Time Perspective: Prospective
Official Title: Effect of Pasta as Part of Low Glycemic Index Diets on Body Weight and Markers of Adiposity in Humans: A Series of Systematic Reviews and Meta-analyses to Provide Evidence-based Guidance for Nutrition Guidelines Development
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight




Primary Outcome Measures :
  1. Global measures of adiposity with established clinical relevance - body weight [ Time Frame: Up to 20 years ]
    body weight


Secondary Outcome Measures :
  1. Global measures of adiposity with established clinical relevance - BMI [ Time Frame: Up to 20 years ]
    body mass index, BMI

  2. Global measures of adiposity with established clinical relevance - percentage body fat [ Time Frame: Up to 20 years ]
    percentage body fat

  3. Regional measures of adiposity with established clinical relevance - waist circumference [ Time Frame: Up to 20 years ]
    waist circumference

  4. Regional measures of adiposity with established clinical relevance - waist-to-hip ratio [ Time Frame: Up to 20 years ]
    waist-to-hip ratio

  5. Regional measures of adiposity with established clinical relevance - sagittal abdominal diameter [ Time Frame: Up to 20 years ]
    sagittal abdominal diameter

  6. Measures of adiposity by established imaging techniques - visceral adipose tissue [VAT] [ Time Frame: Up to 20 years ]
    visceral adipose tissue [VAT] by imaging modalities



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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 individuals, with the exception of children and pregnant or breast-feeding women, regardless of health status.
Criteria

Inclusion Criteria:

  • Dietary trials in humans
  • Randomized trials
  • Trials greater than or equal to 3 weeks duration
  • Suitable control group
  • Viable outcome data

Exclusion Criteria:

  • No assessment of the glycemic index
  • Co-intervention present (i.e. the study is designed in such a way that the effect of past as part of a low glycemic index or glycemic load diet can not be isolated)
  • Trials looking at the glycemic index of specific foods instead of the diet as a whole
  • Trials that did not include pasta as part of the low GI/GL diet
  • Trials that included pasta in the control diet
  • Trials including pregnant or breast feeding women
  • Non-human studies
  • Non-randomized trials
  • Trials less than 3 weeks duration
  • Lack of a suitable control group
  • No viable endpoint data

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Sievenpiper, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT02961088     History of Changes
Other Study ID Numbers: Toronto3D Pasta 2016
First Posted: November 10, 2016    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be included in the meta-analyses and available online as supplemental material

Keywords provided by John Sievenpiper, University of Toronto:
Systematic review and meta-analysis
Evidence-based medicine (EBM)
Evidence-based nutrition (EBN)
Clinical practice guidelines
Glycemic index
Pasta
Glycemic load
Body weight
Cardiovascular risk factors
Cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Overweight
Metabolic Syndrome X
Prediabetic State
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases