Impact of Breakfast Composition on Glycemic and Incretin Responses in Individuals With Type 2 Diabetes

October 1, 2019 updated by: Jill Kanaley, University of Missouri-Columbia

Effect of a High Protein Breakfast on Glycemic Control, Insulin Sensitivity, and Beta Cell Function in Individuals With Type 2 Diabetes (T2D)

This study examined the effect of a high protein or high carbohydrate breakfast on the glucose and insulin response following the breakfast meal, as well as the subsequent response following the lunch meal.

Study Overview

Status

Completed

Conditions

Detailed Description

Twelve habitual breakfast consumers with type 2 diabetes (T2D) were recruited for the study. They completed two, 7-day conditions in random order with a minimum of a 7-day washout period between study days. They consumed either a high protein (PRO) or high carbohydrate (CHO) breakfast for 6 days of acclimatization, and on the seventh day, they reported to the lab at 0700 hours following a ~12 hour overnight fast and underwent forearm catheterization before a baseline blood draw. The participants consumed the respective breakfast at ~0730 hours. Four hours post-breakfast, subjects consumed a standard lunch meal. Blood samples were taken continuously throughout the 8-hour test day.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 21-55 y of age
  • body mass index (BMI) between 30-40 kg/m2
  • weight stable for the prior 6 months
  • non-smokers
  • minimal alcohol consumption (< 2 drinks per day)
  • type 2 diabetic (diagnosed ≥ 2 y)
  • a fasting glucose level above 120 mg/dL
  • HbA1c between 6.5-9.0%

Exclusion Criteria:

  • insulin
  • β-blockers
  • GLP-1 agonists (e.g. exenatide)
  • dipeptidyl peptidase (DPP) inhibitors
  • weight loss
  • using weight-loss medications
  • pregnant or lactating

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Carb then High Protein Breakfast
A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) followed by a 7-day washout period, and then 7 days of eating a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat).
a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)
Active Comparator: High Protein then High Carb Breakfast
A high protein breakfast - 500 kcal followed by a 7-day washout period, and then 7 days of eating a high carbohydrate breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Glucose Level Post-meal (AUC [0-4])
Time Frame: 0-240 and 240-480
AUC for 4 hr after breakfast and after lunch
0-240 and 240-480

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC)
Time Frame: 0-240 and 240-480
AUC for 4 hr after breakfast and after lunch
0-240 and 240-480

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-meal Insulin Level (AUC [0-4])
Time Frame: 0-240 and 240-480
AUC for 4 hr after breakfast and after lunch
0-240 and 240-480
Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC )
Time Frame: 0-240 and 240-480
AUC for 4 hr after breakfast and after lunch
0-240 and 240-480

Collaborators and Investigators

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

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

December 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 3, 2014

Study Record Updates

Last Update Posted (Actual)

October 3, 2019

Last Update Submitted That Met QC Criteria

October 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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