Meta-analyses of the Effect of Tree Nuts on Glycemic Control and Features of the Metabolic Syndrome
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Purpose
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. Although heart disease risk reduction claims for nuts have been permitted in the U.S. and general dietary guidelines and recommendations from heart associations recommend the consumption of nuts for heart protection, diabetes associations have not addressed nuts in their most recent recommendations. This omission is despite heart disease being a major cause of death in diabetes. There remains insufficient information on the usefulness of these foods in diabetes. To improve evidence-based guidance for tree nut recommendations, the investigators propose to conduct a systematic review of the effect of tree nuts on diabetes control and features of the metabolic syndrome. The systematic review process allows the combining of the results from many small 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 tree nuts has different effects between men and women, in different age groups and background disease states, and whether or not the effect of tree nuts depends on the dose and background diet. The findings of this proposed knowledge synthesis will help improve the health of Canadians through informing diabetes association recommendations and heart association recommendations where they relate to diabetes.
| Condition | Intervention |
|---|---|
|
Diabetes Prediabetes Dysglycemia Overweight Obesity Dyslipidemia Hypertension Metabolic Syndrome Cardiovascular Disease Risk |
Other: Tree nuts |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Effect of Tree Nuts on Glycemic Control and Features of the Metabolic Syndrome: A Systematic Review and Meta-analysis of Controlled Dietary Trials to Provide Evidence-based Guidance for Nutrition Guidelines Development |
- Glycemic control measures [ Time Frame: Up to 1.5-years ] [ Designated as safety issue: No ]Glycated blood proteins (HbA1c, total glycated hemoglobin, fructosamine, glycated albumin), fasting glucose, fasting insulin, and the homeostasis model assessment of insulin resistance (HOMA-IR)
- Metabolic syndrome measures [ Time Frame: Up to 1.5-years ] [ Designated as safety issue: No ]Harmonized metabolic syndrome diagnostic measures (waist circumference, TG, HDL-C, blood pressure, fasting glucose)
| Estimated Enrollment: | 1 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
-
Other: Tree nuts
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Varied
Inclusion Criteria:
- Dietary trials in humans
- Randomized treatment allocation
- >=3-weeks
- Suitable control (i.e. isocaloric exchange of other dietary components for tree nuts)
- viable endpoint data
Exclusion Criteria:
- Non-human studies
- Nonrandomized treatment allocation
- 3-weeks
- Lack of a suitable control (non-isocaloric)
- no viable endpoint data
Contacts and Locations| Canada, Ontario | |
| The Toronto 3D (Diet, Digestive tract and Disease) Knowledge Synthesis and Clinical Trials Unit, Clinical Nutrition and Risk Factor Modification Centre, St. Micheal's Hospital | |
| Toronto, Ontario, Canada, M5C 2T2 | |
| Study Director: | John L Sievenpiper, MD, PhD | Department of Pathology and Molecular Medicine, McMaster University and Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital |
| Study Director: | Russell J de Souza, ScD, RD | Department of Epidemiology and Biostatistics, McMaster University and Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital |
| Principal Investigator: | Cyril WC Kendall, PhD | Department of Nutritional Sciences and Medicine, University of Toronto and Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital |
| Principal Investigator: | David JA Jenkins, MD, PhD, DSc | Department of Nutritional Sciences and Medicine, University of Toronto and Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital |
More Information
Publications:
| Responsible Party: | John Sievenpiper, Adjunct Research Fellow, University of Toronto |
| ClinicalTrials.gov Identifier: | NCT01630980 History of Changes |
| Other Study ID Numbers: | INC 2012 KRS |
| Study First Received: | May 18, 2012 |
| Last Updated: | June 26, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Toronto:
|
Systematic review and meta-analysis Evidence-based medicine (EBM) Evidence-based nutrition (EBN) Clinical practice guidelines Clinical trials Tree nuts Cardiometabolic risk factors |
Triglycerides Cholesterol Glycemic control Insulin resistance Body weight Blood pressure |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Hypertension Obesity Dyslipidemias Glucose Intolerance Prediabetic State Overweight Metabolic Syndrome X Vascular Diseases Overnutrition Nutrition Disorders |
Body Weight Signs and Symptoms Lipid Metabolism Disorders Metabolic Diseases Hyperglycemia Glucose Metabolism Disorders Diabetes Mellitus Endocrine System Diseases Insulin Resistance Hyperinsulinism |
ClinicalTrials.gov processed this record on May 16, 2013