NCT02180646

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Dec 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2014

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

January 18, 2017

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

1.3 years

First QC Date

June 30, 2014

Results QC Date

September 30, 2016

Last Update Submit

October 1, 2019

Conditions

Type 2 Diabetes

Keywords

GLP-1GIPsecond meal phenomenatype 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Plasma Glucose Level Post-meal (AUC [0-4])

    AUC for 4 hr after breakfast and after lunch

    0-240 and 240-480

Secondary Outcomes (1)

  • Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC)

    0-240 and 240-480

Other Outcomes (2)

  • Post-meal Insulin Level (AUC [0-4])

    0-240 and 240-480

  • Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC )

    0-240 and 240-480

Study Arms (2)

High Carb then High Protein Breakfast

ACTIVE COMPARATOR

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 breakfastOther: High carb breakfast

High Protein then High Carb Breakfast

ACTIVE COMPARATOR

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 breakfastOther: High carb breakfast

Interventions

High protein breakfastOTHER

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

High Carb then High Protein BreakfastHigh Protein then High Carb Breakfast
High carb breakfastOTHER

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

High Carb then High Protein BreakfastHigh Protein then High Carb Breakfast

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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%

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25733459DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr Jill Kanaley
Organization
University of Missouri
kanaleyj@missouri.edu
573-882-2519

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

June 30, 2014

First Posted

July 3, 2014

Study Start

December 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 3, 2019

Results First Posted

January 18, 2017

Record last verified: 2019-10