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

Patients With Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03727854
• Other study ID #: H-1804-120-940
• Status: Completed
• Phase: N/A
• Start date: August 27, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Patients With Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c From Baseline		0 week, 12 weeks
Secondary	Change in Fasting Blood Glucose Level From Baseline		0 week, 12 weeks
Secondary	Change in Body Weight From Baseline		0 week, 12 weeks
Secondary	Change in Waist Circumference From Baseline		0 week, 12 weeks
Secondary	Change in Blood Triglyceride Level From Baseline		0 week, 12 weeks
Secondary	Change in Blood High-density Lipoprotein Level From Baseline		0 week, 12 weeks
Secondary	Change in Blood Low-density Lipoprotein Level From Baseline		0 week, 12 weeks
Secondary	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
Secondary	Change in Homeostatic Model Assessment of ß-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