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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Premeal protein group
    • Premeal protein enriched bar with dietary modification
  • Other: Dietary modofication only group
    • Dietary modification only

Clinical Trial Outcome Measures

Primary Measures

  • Change in HbA1c From Baseline
    • Time Frame: 0 week, 12 weeks

Secondary Measures

  • Change in Fasting Blood Glucose Level From Baseline
    • Time Frame: 0 week, 12 weeks
  • Change in Body Weight From Baseline
    • Time Frame: 0 week, 12 weeks
  • Change in Waist Circumference From Baseline
    • Time Frame: 0 week, 12 weeks
  • Change in Blood Triglyceride Level From Baseline
    • Time Frame: 0 week, 12 weeks
  • Change in Blood High-density Lipoprotein Level From Baseline
    • Time Frame: 0 week, 12 weeks
  • Change in Blood Low-density Lipoprotein Level From Baseline
    • Time Frame: 0 week, 12 weeks
  • Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline
    • Time Frame: 0 week, 12 weeks
    • 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
    • Time Frame: 0 week, 12 weeks
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Young Min Cho, Professor – Seoul National University Hospital
  • Overall Official(s)
    • Young Min Cho, MD, PhD, Principal Investigator, Seoul National University Hospital

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