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

Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Long-term Glycemic Control in Patients With Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Patients With Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Premeal protein enriched bar; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Premeal protein group; Premeal protein enriched bar with dietary modification	Dietary supplement: Premeal protein enriched bar; Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).; Behavioral: Dietary modification; Subjects in this group will follow diabetes diet education.
Other: Dietary modofication only group; Dietary modification only	Behavioral: Dietary modification; Subjects in this group will follow diabetes diet education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c From Baseline	0 week, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fasting Blood Glucose Level From Baseline		0 week, 12 weeks
Change in Body Weight From Baseline		0 week, 12 weeks
Change in Waist Circumference From Baseline		0 week, 12 weeks
Change in Blood Triglyceride Level From Baseline		0 week, 12 weeks
Change in Blood High-density Lipoprotein Level From Baseline		0 week, 12 weeks
Change in Blood Low-density Lipoprotein Level From Baseline		0 week, 12 weeks
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.	0 week, 12 weeks
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.	0 week, 12 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: type 2 diabetes; glycemic control; long term; protein-enriched bar
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: H-1804-120-940

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No