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

NCT ID: NCT02982330

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low Carbohydrate Breakfast

Breakfast composition containing \<10% carbohydrate, 75% fat, 15% protein Matched calories

Group Type EXPERIMENTAL

Low Carbohydrate Breakfast

Intervention Type BEHAVIORAL

A low carbohydrate breakfast containing \<10% carbohydrate, \~75% fat, and 15% protein. Matched for calories to the active comparator arm.

Guidelines Breakfast

Intervention Type BEHAVIORAL

A low fat breakfast containing \~55% carbohydrate, \<30% fat, and 15% protein. Matched for calories to the experimental arm.

Guidelines Breakfast

Breakfast composition containing 55% carbohydrate, 30% fat, 15% protein Matched calories

Group Type ACTIVE_COMPARATOR

Low Carbohydrate Breakfast

Intervention Type BEHAVIORAL

A low carbohydrate breakfast containing \<10% carbohydrate, \~75% fat, and 15% protein. Matched for calories to the active comparator arm.

Guidelines Breakfast

Intervention Type BEHAVIORAL

A low fat breakfast containing \~55% carbohydrate, \<30% fat, and 15% protein. Matched for calories to the experimental arm.

Interventions

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Low Carbohydrate Breakfast

A low carbohydrate breakfast containing \<10% carbohydrate, \~75% fat, and 15% protein. Matched for calories to the active comparator arm.

Intervention Type BEHAVIORAL

Guidelines Breakfast

A low fat breakfast containing \~55% carbohydrate, \<30% fat, and 15% protein. Matched for calories to the experimental arm.

Intervention Type BEHAVIORAL

Other Intervention Names

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Low-fat Breakfast

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Little

Dr Jonathan P Little

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan P Little, PhD

Role: PRINCIPAL_INVESTIGATOR

UBC Okanagan

Locations

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University of British Columbia, Okanagan.

Kelowna, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 30968140 (View on PubMed)

Other Identifiers

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H16--00377

Identifier Type: -

Identifier Source: org_study_id