NCT02589028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 29, 2017

Status Verified

October 1, 2015

Enrollment Period

9 months

First QC Date

October 26, 2015

Last Update Submit

November 27, 2017

Conditions

Diabetes Mellitus

Keywords

diabetes mellitusincretin hormoneglucose levelGLP-1GIPpremeal protein

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • 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 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

  • 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

  • +5 more secondary outcomes

Study Arms (2)

premeal protein bar first

EXPERIMENTAL

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

breakfast first

OTHER

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

Interventions

premeal protein-enriched bar intakeDIETARY_SUPPLEMENT

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

Also known as: premeal protein bar
premeal protein bar first
breakfast follows by protein barOTHER

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.

breakfast first

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Young Min Cho, MD, PHD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2015

First Posted

October 28, 2015

Study Start

October 1, 2015

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

November 29, 2017

Record last verified: 2015-10

Locations

KR(1)