A Series of Systematic Reviews and Meta-analyses of the Effect of Vegetarian/Vegan Diets on Cardiometabolic Risk

NCT02600377 | Unknown

• 1 other identifier: Vegetarian diets 2015
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

Vegetarian and vegan diets have been shown to reduce chronic disease risk, including diabetes and cardiovascular disease, as well as several cardiometabolic risk factors. Whether vegetarian and/or vegan dietary patterns improve cardiometabolic risk factors in individuals with diabetes remains unclear. 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 to distinguish the effect of vegetarian and/or vegan diets on the prevention and management of diabetes. 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

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Up to 1.5-years

Secondary Outcomes (11)

• Fasting glucose

  Up to 1.5-years

• Fasting insulin

  Up to 1.5-years

• LDL-cholesterol

  Up to 1.5-years

• non-HDL-cholesterol

  Up to 1.5-years

• HDL-cholesterol

  Up to 1.5-years

Interventions

Vegetarian diet OTHER

Diets that omit all animal products (vegan diet) or all animal products with the exception of eggs and/or dairy products (vegetarian)

Also known as: Vegan diet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Diabetes

You may qualify if:

• Dietary trials in humans
• Randomized treatment allocation
• ≥3 weeks
• Suitable control (i.e. isocaloric diet that is not vegetarian or vegan)
• Viable endpoint data

You may not qualify if:

• Non-human studies
• Non-randomized treatment allocation
• \<3 weeks
• Lack of a suitable control (i.e. non-isocaloric)
• No viable endpoint data

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canada Research Chairs Endowment of the Federal Government of Canada: collaborator
• The Physicians' Services Incorporated Foundation: collaborator
• Canadian Diabetes Association: collaborator

Related Publications (1)

• Viguiliouk E, Kendall CW, Kahleova H, Rahelic D, Salas-Salvado J, Choo VL, Mejia SB, Stewart SE, Leiter LA, Jenkins DJ, Sievenpiper JL. Effect of vegetarian dietary patterns on cardiometabolic risk factors in diabetes: A systematic review and meta-analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1133-1145. doi: 10.1016/j.clnu.2018.05.032. Epub 2018 Jun 13.

  PMID: 29960809 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Diet, Vegetarian; Diet, Vegan

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FRCPC

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 9, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 9, 2015

Record last verified: 2015-11