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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Dietary Supplement: premeal protein-enriched bar intake; Other: breakfast follows by protein bar

• Registration Number: NCT02589028
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-28
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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%

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
premeal protein bar first	premeal protein-enriched bar intake	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
breakfast first	breakfast follows by protein bar	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 C-peptide 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
plasma glucagon level after breakfast	-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
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 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 glucagon level after breakfast	-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of