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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: High protein breakfast; Other: High carb breakfast

• Registration Number: NCT02180646
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

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.

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 Timeline

• Study Start: 2011-12
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-03
• Results First Submitted: 2016-09-30
• Results First Submitted QC: 2016-11-22
• Results First Posted: 2017-01-18
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Carb then High Protein Breakfast	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).
High Protein then High Carb Breakfast	High protein 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)
High Carb then High Protein Breakfast	High carb 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).
High Protein then High Carb Breakfast	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)

Primary Outcome Measures

Name	Time	Method
Plasma Glucose Level Post-meal (AUC [0-4])	0-240 and 240-480	AUC for 4 hr after breakfast and after lunch

Secondary Outcome Measures

Name	Time	Method
Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC)	0-240 and 240-480	AUC for 4 hr after breakfast and after lunch