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

NCT ID: NCT03727854

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-27
• Study Completion Date: 2019-12-31

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.

Conditions

Patients With Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Premeal protein group

Premeal protein enriched bar with dietary modification

Group Type: EXPERIMENTAL

Premeal protein enriched bar

Intervention Type: DIETARY_SUPPLEMENT

Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).

Dietary modification

Intervention Type: BEHAVIORAL

Subjects in this group will follow diabetes diet education.

Dietary modofication only group

Dietary modification only

Group Type: OTHER

Dietary modification

Intervention Type: BEHAVIORAL

Subjects in this group will follow diabetes diet education.

Interventions

Premeal protein enriched bar

Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).

Intervention Type: DIETARY_SUPPLEMENT

Dietary modification

Subjects in this group will follow diabetes diet education.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Young Min Cho

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Young Min Cho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H-1804-120-940

Identifier Type: -

Identifier Source: org_study_id