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

NCT ID: NCT02589028

Last Updated: 2017-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-09-30

Brief Summary

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.

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.

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus; incretin hormone; glucose level; GLP-1; GIP; premeal protein

Study Design

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

Study Groups

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

Group Type: EXPERIMENTAL

premeal protein-enriched bar intake

Intervention Type: DIETARY_SUPPLEMENT

Premeal protein bar is provided 30 minutes before breakfast. Participants have to eat protein bar with in 5 minutes with 150ml of water.

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

Group Type: OTHER

breakfast follows by protein bar

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Other Intervention Names

premeal protein bar

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Young Min Cho, MD, PHD

Role: STUDY_CHAIR

Associate Professor Division of Endocrinology and Metabolism Department of Internal Medicine Seoul National University College of Medicine

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

H-1504-103-666

Identifier Type: -

Identifier Source: org_study_id