Impact of a Low Carbohydrate Breakfast on Glucose Control in Type 2 Diabetes

October 12, 2017 updated by: Jonathan Little, University of British Columbia
Large glucose excursions at breakfast are prevalent in type 2 diabetes and can contribute to sustained hyperglycaemia across the day. Lowering consumption of dietary carbohydrate is known to reduce post-meal glucose excursions but it is unknown whether lowering the carbohydrate at breakfast only will impact subsequent post meal glucose excursions throughout the day. The aim of this study is to examine, under free living conditions and using typical dietary patterns, whether eating a breakfast low in carbohydrate can lower daily post-meal glycemia when compared to consuming a low-fat breakfast (per the current diabetes guidelines).

Study Overview

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Kelowna, British Columbia, Canada, V1V 1V7
        • University of British Columbia, Okanagan.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Physician-diagnosed Type 2 Diabetes (>6 months)

Exclusion Criteria:

  • Exogenous Insulin
  • A1c > 9%
  • Cardiovascular, liver, or renal other disease
  • Breakfast and meal skippers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Carbohydrate Breakfast
Breakfast composition containing <10% carbohydrate, 75% fat, 15% protein Matched calories
A low carbohydrate breakfast containing <10% carbohydrate, ~75% fat, and 15% protein. Matched for calories to the active comparator arm.
A low fat breakfast containing ~55% carbohydrate, <30% fat, and 15% protein. Matched for calories to the experimental arm.
Other Names:
  • Low-fat Breakfast
Active Comparator: Guidelines Breakfast
Breakfast composition containing 55% carbohydrate, 30% fat, 15% protein Matched calories
A low carbohydrate breakfast containing <10% carbohydrate, ~75% fat, and 15% protein. Matched for calories to the active comparator arm.
A low fat breakfast containing ~55% carbohydrate, <30% fat, and 15% protein. Matched for calories to the experimental arm.
Other Names:
  • Low-fat Breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incremental area under the glucose curve (continuous glucose monitor)
Time Frame: 24 hour (one day)
24 hour (one day)

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean Blod Glucose (continuous glucose monitor)
Time Frame: 24 hours (one day)
24 hours (one day)

Other Outcome Measures

Outcome Measure
Time Frame
Glycemic Variability (continuous glucose monitor)
Time Frame: 24 hours (one day)
24 hours (one day)
Satiety VAS 100
Time Frame: Before and after meals (one day)
Before and after meals (one day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jonathan P Little, PhD, UBC Okanagan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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