Clinical trial NCT03727854: 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
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Type 2 Diabetes
Keywords: protein-enriched bar
glycemic control
type 2 diabetes
long term
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in HbA1c From Baseline
timeFrame: 0 week, 12 weeks
Secondary outcomes:
measure: Change in Fasting Blood Glucose Level From Baseline
timeFrame: 0 week, 12 weeks
measure: Change in Body Weight From Baseline
timeFrame: 0 week, 12 weeks
measure: Change in Waist Circumference From Baseline
timeFrame: 0 week, 12 weeks
measure: Change in Blood Triglyceride Level From Baseline
timeFrame: 0 week, 12 weeks
measure: Change in Blood High-density Lipoprotein Level From Baseline
timeFrame: 0 week, 12 weeks
measure: Change in Blood Low-density Lipoprotein Level From Baseline
timeFrame: 0 week, 12 weeks
measure: Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline
timeFrame: 0 week, 12 weeks
measure: Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline
timeFrame: 0 week, 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Young Min Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: