Meta-analysis of Oats for Diabetes Prevention and Management

NCT04631913 | Unknown

• 1 other identifier: QUAKER - Oats & glycemia
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Oats are a commonly consumed source of viscous soluble fibre, which has an established role in cardiovascular disease risk management including in cholesterol and glycemic control. Oat beta-glucan is recognized for its cholesterol-lowering effects with approved health claims in Canada, US and Europe. However, the efficacy of oat beta-glucan on glycemic control is not clear. We propose to conduct a systematic review and meta-analysis to explore the efficacy of whole grain oats and oat beta-glucan on markers of glycemic control in people with, without or at risk for diabetes.

Conditions

Healthy; Diabetes; Metabolic Syndrome; Overweight and Obesity

Keywords

oats; viscous dietary fiber; beta-glucan; glycemic control; diabetes

Outcome Measures

Primary Outcomes (7)

• Glycemic control - HbA1c

  Mean difference

  At least 2 weeks

• Glycemic control - Fasting plasma glucose

  Mean difference

  At least 2 weeks

• Glycemic control - 2h-plasma glucose (2h-PG)

  Mean difference

  at least 2 weeks

• Glycemic control - Fasting blood insulin

  Mean difference

  At least 2 weeks

• Insulin Sensitivity - hepatic

  Ratio of means (aggregate of HOMA-IR, hyperinsulinemic euglycemic clamp hepatic insulin sensitivity)

  At least 2 weeks

• Insulin Sensitivity - whole body

  Ratio of means (aggregate of Matsuda OGTT-ISI, frequently sampled intravenous glucose tolerance test (FSIGTT), hyperinsulinemic euglycemic clamp hyperinsulinemic clamp whole body insulin sensitivity)

  At least 2 weeks

• Beta-cell function

  Ratio of means (aggregate of insulin secretion index, ISSI2)

  At least 2 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult humans with, without or at risk fo diabetes

You may qualify if:

• Oat or oat beta-glucan intervention
• Adult human dietary trial
• Randomized treatment allocation
• ≥ 2 weeks intervention period
• Suitable control (i.e. non-oat control)
• Viable endpoint data

You may not qualify if:

• Non-human studies
• Non-randomized treatment allocation
• \< 2 weeks intervention period
• Lack of a suitable control
• No viable endpoint data

Sponsors & Collaborators

• University of Toronto: lead
• Quaker Oats Company: collaborator

Study Sites (1)

University of Toronto

Toronto, Ontario, M5C 2T2, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Metabolic Syndrome; Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 17, 2020
• Study Start: August 14, 2020
• Primary Completion: July 31, 2021
• Study Completion: November 30, 2021
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

CA (1)