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

NCT02961088 | Unknown

• 1 other identifier: Toronto3D Pasta 2016
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes; Prediabetes; Overweight; Obesity; Metabolic Syndrome; Cardiovascular Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Global measures of adiposity with established clinical relevance - body weight

  body weight

  Up to 20 years

Secondary Outcomes (6)

• Global measures of adiposity with established clinical relevance - BMI

  Up to 20 years

• Global measures of adiposity with established clinical relevance - percentage body fat

  Up to 20 years

• Regional measures of adiposity with established clinical relevance - waist circumference

  Up to 20 years

• Regional measures of adiposity with established clinical relevance - waist-to-hip ratio

  Up to 20 years

• Regional measures of adiposity with established clinical relevance - sagittal abdominal diameter

  Up to 20 years

Interventions

Pasta as part of a low GI/GL diet OTHER

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• Toronto 3D Knowledge Synthesis and Clinical Trials foundation: collaborator

Related Publications (5)

• Mirrahimi A, de Souza RJ, Chiavaroli L, Sievenpiper JL, Beyene J, Hanley AJ, Augustin LS, Kendall CW, Jenkins DJ. Associations of glycemic index and load with coronary heart disease events: a systematic review and meta-analysis of prospective cohorts. J Am Heart Assoc. 2012 Oct;1(5):e000752. doi: 10.1161/JAHA.112.000752. Epub 2012 Oct 25.

  PMID: 23316283 BACKGROUND

• Turner-McGrievy GM, Jenkins DJ, Barnard ND, Cohen J, Gloede L, Green AA. Decreases in dietary glycemic index are related to weight loss among individuals following therapeutic diets for type 2 diabetes. J Nutr. 2011 Aug;141(8):1469-74. doi: 10.3945/jn.111.140921. Epub 2011 Jun 8.

  PMID: 21653575 BACKGROUND

• Larsen TM, Dalskov SM, van Baak M, Jebb SA, Papadaki A, Pfeiffer AF, Martinez JA, Handjieva-Darlenska T, Kunesova M, Pihlsgard M, Stender S, Holst C, Saris WH, Astrup A; Diet, Obesity, and Genes (Diogenes) Project. Diets with high or low protein content and glycemic index for weight-loss maintenance. N Engl J Med. 2010 Nov 25;363(22):2102-13. doi: 10.1056/NEJMoa1007137.

  PMID: 21105792 BACKGROUND

• Jenkins DJ, Kendall CW, Augustin LS, Mitchell S, Sahye-Pudaruth S, Blanco Mejia S, Chiavaroli L, Mirrahimi A, Ireland C, Bashyam B, Vidgen E, de Souza RJ, Sievenpiper JL, Coveney J, Leiter LA, Josse RG. Effect of legumes as part of a low glycemic index diet on glycemic control and cardiovascular risk factors in type 2 diabetes mellitus: a randomized controlled trial. Arch Intern Med. 2012 Nov 26;172(21):1653-60. doi: 10.1001/2013.jamainternmed.70.

  PMID: 23089999 BACKGROUND

• Chiavaroli L, Kendall CWC, Braunstein CR, Blanco Mejia S, Leiter LA, Jenkins DJA, Sievenpiper JL. Effect of pasta in the context of low-glycaemic index dietary patterns on body weight and markers of adiposity: a systematic review and meta-analysis of randomised controlled trials in adults. BMJ Open. 2018 Apr 2;8(3):e019438. doi: 10.1136/bmjopen-2017-019438.

  PMID: 29615407 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Prediabetic State; Overweight; Obesity; Metabolic Syndrome; Cardiovascular Diseases; Body Weight

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism

Study Design

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

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 10, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2018
• Last Updated: November 17, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share