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Effect of Premeal Protein-bar on Glycemic Control in Patients With Type 2 Diabetes

Primary Purpose

Patients With Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Premeal protein enriched bar
Dietary modification
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Patients With Type 2 Diabetes focused on measuring protein-enriched bar, glycemic control, type 2 diabetes, long term

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI 18.5~35 kg/m2
  • Type 2 diabetes patients
  • Fasting blood glucose ≥ 126 mg/dl or
  • HbA1c ≥ 6.5% or
  • Subjects who were previously diagnosed with type 2 diabetes and who have been treated with lifestyle modification only, oral anti-diabetic drugs or basal insulin.

Exclusion Criteria:

  • HbA1c < 6.5% or > 10%
  • Subjects using insulin other than basal insulin
  • Subjects who have newly started or have changed anti diabetic drugs within 3 months
  • Subjects who are allergic to grains, nuts, legumes and milk
  • Previous history of gastrointestinal surgery (except for hemorrhoid surgery, appendectomy surgery and hernia surgery)
  • Subjects with chronic unstable disease
  • Subjects with cognitive impairments who are not able to follow the study protocol
  • Females who are pregnant or doing breast feeding
  • Subjects with Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels of higher than 3 times of upper normal ranges
  • Subjects with hemoglobin level of less than 10.0 g/dL
  • Subjects with alcohol addiction or drug abuse

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Premeal protein group

Dietary modofication only group

Arm Description

Premeal protein enriched bar with dietary modification

Dietary modification only

Outcomes

Primary Outcome Measures

Change in HbA1c From Baseline

Secondary Outcome Measures

Change in Fasting Blood Glucose Level From Baseline
Change in Body Weight From Baseline
Change in Waist Circumference From Baseline
Change in Blood Triglyceride Level From Baseline
Change in Blood High-density Lipoprotein Level From Baseline
Change in Blood Low-density Lipoprotein Level From Baseline
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405.
Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405.

Full Information

First Posted
October 31, 2018
Last Updated
April 10, 2020
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03727854
Brief Title
Effect of Premeal Protein-bar on Glycemic Control in Patients With Type 2 Diabetes
Official Title
Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Long-term Glycemic Control in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the effect of premeal protein-enriched bar in long-term glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who intake premeal protein-enriched bar with dietary modification will be compared to those in subjects who only do the dietary modification.
Detailed Description
Forty subjects with type 2 diabetes will be recruited. Every subject will be randomized in two groups, which are premeal protein bar with dietary modification group and dietary modification only group. The study will be conducted for 12 weeks for each participants. All participants will receive diabetes diet education. Intervention group will consume protein-enriched bar before each meals (at least twice a day) and control group will follow diabetes diet education without other additional supplements. Primary outcome is change of HbA1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose level, body weight, waist circumference, blood lipid level, HOMA-IR and HOMA-beta from baseline for 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Type 2 Diabetes
Keywords
protein-enriched bar, glycemic control, type 2 diabetes, long term

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Premeal protein group
Arm Type
Experimental
Arm Description
Premeal protein enriched bar with dietary modification
Arm Title
Dietary modofication only group
Arm Type
Other
Arm Description
Dietary modification only
Intervention Type
Dietary Supplement
Intervention Name(s)
Premeal protein enriched bar
Intervention Description
Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).
Intervention Type
Behavioral
Intervention Name(s)
Dietary modification
Intervention Description
Subjects in this group will follow diabetes diet education.
Primary Outcome Measure Information:
Title
Change in HbA1c From Baseline
Time Frame
0 week, 12 weeks
Secondary Outcome Measure Information:
Title
Change in Fasting Blood Glucose Level From Baseline
Time Frame
0 week, 12 weeks
Title
Change in Body Weight From Baseline
Time Frame
0 week, 12 weeks
Title
Change in Waist Circumference From Baseline
Time Frame
0 week, 12 weeks
Title
Change in Blood Triglyceride Level From Baseline
Time Frame
0 week, 12 weeks
Title
Change in Blood High-density Lipoprotein Level From Baseline
Time Frame
0 week, 12 weeks
Title
Change in Blood Low-density Lipoprotein Level From Baseline
Time Frame
0 week, 12 weeks
Title
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline
Description
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405.
Time Frame
0 week, 12 weeks
Title
Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline
Description
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405.
Time Frame
0 week, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI 18.5~35 kg/m2 Type 2 diabetes patients Fasting blood glucose ≥ 126 mg/dl or HbA1c ≥ 6.5% or Subjects who were previously diagnosed with type 2 diabetes and who have been treated with lifestyle modification only, oral anti-diabetic drugs or basal insulin. Exclusion Criteria: HbA1c < 6.5% or > 10% Subjects using insulin other than basal insulin Subjects who have newly started or have changed anti diabetic drugs within 3 months Subjects who are allergic to grains, nuts, legumes and milk Previous history of gastrointestinal surgery (except for hemorrhoid surgery, appendectomy surgery and hernia surgery) Subjects with chronic unstable disease Subjects with cognitive impairments who are not able to follow the study protocol Females who are pregnant or doing breast feeding Subjects with Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels of higher than 3 times of upper normal ranges Subjects with hemoglobin level of less than 10.0 g/dL Subjects with alcohol addiction or drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Min Cho, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Premeal Protein-bar on Glycemic Control in Patients With Type 2 Diabetes

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