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

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ClinicalTrials.gov Identifier: NCT02589028
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Dietary Supplement: premeal protein-enriched bar intake Other: breakfast follows by protein bar Not Applicable

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Study Start Date : October 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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 Name: premeal protein bar

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589028


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
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

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02589028     History of Changes
Other Study ID Numbers: H-1504-103-666
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: October 2015

Keywords provided by Seoul National University Hospital:
diabetes mellitus
incretin hormone
glucose level
GLP-1
GIP
premeal protein

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs