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

NCT ID: NCT02180646

Last Updated: 2019-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-04-30

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

High protein breakfast

Intervention Type: OTHER

a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)

High carb breakfast

Intervention Type: OTHER

a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)

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)

Group Type: ACTIVE_COMPARATOR

High protein breakfast

Intervention Type: OTHER

a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)

High carb breakfast

Intervention Type: OTHER

a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)

Interventions

High protein breakfast

a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)

Intervention Type: OTHER

High carb breakfast

a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Egg Board

OTHER

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jill Kanaley

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 25733459 (View on PubMed)

Other Identifiers

b2d2-01

Identifier Type: -

Identifier Source: org_study_id