Impact of a Low Carbohydrate Breakfast on Glucose Control in Type 2 Diabetes
1 other identifier
interventional
27
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 29, 2016
CompletedFirst Posted
Study publicly available on registry
December 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedOctober 13, 2017
October 1, 2017
8 months
November 29, 2016
October 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Incremental area under the glucose curve (continuous glucose monitor)
24 hour (one day)
Secondary Outcomes (1)
Mean Blod Glucose (continuous glucose monitor)
24 hours (one day)
Other Outcomes (2)
Glycemic Variability (continuous glucose monitor)
24 hours (one day)
Satiety VAS 100
Before and after meals (one day)
Study Arms (2)
Low Carbohydrate Breakfast
EXPERIMENTALBreakfast composition containing \<10% carbohydrate, 75% fat, 15% protein Matched calories
Guidelines Breakfast
ACTIVE COMPARATORBreakfast composition containing 55% carbohydrate, 30% fat, 15% protein Matched calories
Interventions
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.
Eligibility Criteria
You may qualify if:
- Physician-diagnosed Type 2 Diabetes (\>6 months)
You may not qualify if:
- Exogenous Insulin
- A1c \> 9%
- Cardiovascular, liver, or renal other disease
- Breakfast and meal skippers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of British Columbia, Okanagan.
Kelowna, British Columbia, V1V 1V7, Canada
Related Publications (1)
Chang CR, Francois ME, Little JP. Restricting carbohydrates at breakfast is sufficient to reduce 24-hour exposure to postprandial hyperglycemia and improve glycemic variability. Am J Clin Nutr. 2019 May 1;109(5):1302-1309. doi: 10.1093/ajcn/nqy261.
PMID: 30968140DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan P Little, PhD
UBC Okanagan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Jonathan P Little
Study Record Dates
First Submitted
November 29, 2016
First Posted
December 5, 2016
Study Start
November 1, 2016
Primary Completion
July 1, 2017
Study Completion
August 1, 2017
Last Updated
October 13, 2017
Record last verified: 2017-10