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

Seoul National University

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: breakfast follows by protein bar; Dietary Supplement: premeal protein-enriched bar intake

Study type: Interventional

Funder types: Other

Identifiers

NCT02589028

H-1504-103-666

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

premeal protein bar first

Experimental group

Description:

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

Treatment:

Dietary Supplement: premeal protein-enriched bar intake

breakfast first

Other group

Description:

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

Treatment:

Other: breakfast follows by protein bar