The Effects of Premeal Consumption of Protein-enriched Bar on Blood Glucose Level and Secretion of Hormones

The Effects of Premeal Consumption of Protein-enriched Bar on Blood Glucose Level and Secretion of Hormones in Healthy Adults and Patients With Type 2 Diabetes

The aim of this study is to explore premeal protein-enriched bar effect in postprandial glucose levels and concentration of plasma incretin hormones [glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP)] in healthy subjects and those with type 2 diabetes.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: premeal protein-enriched bar intake; Other: breakfast follows by protein bar

Detailed Description

Fifteen healthy subjects and fifteen subjects with type 2 diabetes treated by diet and/or metformin, SU, DPP4 inhibitors will be recruited. Every subject will studied on 2 separate days in random order with 1-2 week intervals. These participants will consume protein enriched bar followed by a standardized high-glycemic-index breakfast in a hospital setting or breakfast followed protein enriched bar in a cross-over fashion. Blood sampling will be done at the moment of start of breakfast (0 min) and then 10, 20, 30, 60, 90, 120, 150, 180 min. Plasma glucose levels, total/active GLP-1, GIP, insulin, C-peptide, glucagon will be measured. Incremental area under the curve (iAUC) of glucose level and hormone from 0 min to 180 min will be calculated.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI 18.5~35 kg/m2

• Healthy volunteer:

  • never diagnosed by diabetes and
  • fasting plasma glucose <=100mg/dl and HbA1c <6.0%

• participants with diabetes

  • diagnosed by diabetes
  • if treated by diet, HbA1c 6.0~9.0%
  • if treated by metformin or SU, HbA1c 6.0~10.0%
  • if treated by DPP4 inhibitor HbA1c 6.0~9.0%

Exclusion Criteria:

• Those who diagnosed by Type 1 diabetes
• History of DKA
• History of insulin therapy
• Allergy to wheat, flour, nuts, milk
• Pregnancy/lactation
• AST or ALT >2.5 times of upper normal reference range
• eGFR <30 mL/min/1.73m2
• Hb <10g/dl
• History of GI surgery (except hemorrhoidectomy, appendectomy)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: premeal protein bar first; intervention: premeal protein-enriched bar intake; protein enriched bar(total serving: 30g, 43.28% carbohydrate; 1.29% fat; 40.39% protein; 42.63% fiber) will be given 30 minutes before breakfast; protein enriched bar is provided with 150 ml of water; amount of protein bar : 30g; breakfast : plain bagel, cream cheese, strawberry jam, orange juice 210ml	Dietary supplement: premeal protein-enriched bar intake; Premeal protein bar is provided 30 minutes before breakfast. Participants have to eat protein bar with in 5 minutes with 150ml of water.; Other Names: premeal protein bar
Other: breakfast first; intervention: breakfast follows by protein bar; protein enriched bar is provided with 150 ml of water shortly after breakfast; amount of protein bar : 30g; breakfast : plain bagel, cream cheese, strawberry jam, orange juice 210ml	Other: breakfast follows by protein bar; Participants have to eat provided breakfast within 30 minutes. It is recommended for participants to eat protein bar shortly after finishing breakfast within 5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
plasma glucose level after breakfast	-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve (AUC) of plasma glucose level after breakfast	-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

Secondary Outcome Measures

Outcome Measure	Time Frame
plasma total/active GLP-1 level after breakfast	-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma total/active GLP-1 level after breakfast	-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma GIP level after breakfast	-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma GIP level after breakfast	-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma insulin level after breakfast	-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma insulin level after breakfast	-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma C-peptide level after breakfast	-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma C-peptide level after breakfast	-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
plasma glucagon level after breakfast	-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve of plasma glucagon level after breakfast	-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Young Min Cho, MD, PHD, Associate Professor Division of Endocrinology and Metabolism Department of Internal Medicine Seoul National University College of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): November 29, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: GLP-1; diabetes mellitus; GIP; glucose level; incretin hormone; premeal protein
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: H-1504-103-666