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Completed

NCT Number: NCT02589028

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

premeal protein-enriched bar intake

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.

Other names: premeal protein bar

breakfast follows by protein bar

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.

Primary outcomes

  1. plasma glucose level after breakfast

    Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

  2. Area under the curve (AUC) of plasma glucose level after breakfast

    Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

Secondary outcomes

  1. plasma total/active GLP-1 level after breakfast

    Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

  2. Area under the curve of plasma total/active GLP-1 level after breakfast

    Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

  3. plasma GIP level after breakfast

    Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

  4. Area under the curve of plasma GIP level after breakfast

    Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

  5. plasma insulin level after breakfast

    Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

  6. Area under the curve of plasma insulin level after breakfast

    Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

  7. plasma C-peptide level after breakfast

    Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

  8. Area under the curve of plasma C-peptide level after breakfast

    Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

  9. plasma glucagon level after breakfast

    Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

  10. Area under the curve of plasma glucagon level after breakfast

    Time frame: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 28, 2015
Registry last updated
Nov 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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