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

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: Type 2 Diabetes
• Intervention / Treatment: Other: High protein breakfast; Other: High carb breakfast

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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).	Other: High protein breakfast; a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat); Other: High carb breakfast; 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)	Other: High protein breakfast; a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat); Other: High carb breakfast; 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])	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)	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])	AUC for 4 hr after breakfast and after lunch	0-240 and 240-480
Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC )	AUC for 4 hr after breakfast and after lunch	0-240 and 240-480

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Collaborators: American Egg Board

Publications and helpful links

General Publications

• Park YM, Heden TD, Liu Y, Nyhoff LM, Thyfault JP, Leidy HJ, Kanaley JA. A high-protein breakfast induces greater insulin and glucose-dependent insulinotropic peptide responses to a subsequent lunch meal in individuals with type 2 diabetes. J Nutr. 2015 Mar;145(3):452-8. doi: 10.3945/jn.114.202549. Epub 2014 Dec 24.

Study record dates

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

• Keywords: GLP-1; type 2 diabetes; GIP; second meal phenomena
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: b2d2-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided