Obesity Clinical Trial
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
Verified date | November 2016 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 1 |
Est. completion date | August 2018 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University of Toronto | Toronto 3D Knowledge Synthesis and Clinical Trials foundation |
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. — View Citation
Larsen TM, Dalskov SM, van Baak M, Jebb SA, Papadaki A, Pfeiffer AF, Martinez JA, Handjieva-Darlenska T, Kunešová M, Pihlsgård 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. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Global measures of adiposity with established clinical relevance - body weight | body weight | Up to 20 years | No |
Secondary | Global measures of adiposity with established clinical relevance - BMI | body mass index, BMI | Up to 20 years | No |
Secondary | Global measures of adiposity with established clinical relevance - percentage body fat | percentage body fat | Up to 20 years | No |
Secondary | Regional measures of adiposity with established clinical relevance - waist circumference | waist circumference | Up to 20 years | No |
Secondary | Regional measures of adiposity with established clinical relevance - waist-to-hip ratio | waist-to-hip ratio | Up to 20 years | No |
Secondary | Regional measures of adiposity with established clinical relevance - sagittal abdominal diameter | sagittal abdominal diameter | Up to 20 years | No |
Secondary | Measures of adiposity by established imaging techniques - visceral adipose tissue [VAT] | visceral adipose tissue [VAT] by imaging modalities | Up to 20 years | No |
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