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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03727854
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Young Min Cho, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE October 31, 2018
First Posted Date  ICMJE November 1, 2018
Last Update Posted Date November 6, 2018
Actual Study Start Date  ICMJE August 27, 2018
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
Change in HbA1c from baseline [ Time Frame: 0 week, 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03727854 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2018)
  • 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 ]
  • Change in Homeostatic Model Assessment of β-cell function (HOMA-beta) from baseline [ Time Frame: 0 week, 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • 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 lipid level (TG, HDH, LDL) from baseline [ Time Frame: 0 week, 12 weeks ]
  • Change in HOMA-IR from baseline [ Time Frame: 0 week, 12 weeks ]
  • Change in HOMA-beta from baseline [ Time Frame: 0 week, 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Premeal Protein-bar on Glycemic Control in Patients With Type 2 Diabetes
Official Title  ICMJE Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Long-term Glycemic Control in Patients With Type 2 Diabetes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Patients With Type 2 Diabetes
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Group1
    Premeal protein enriched bar with dietary modification
    Interventions:
    • Dietary Supplement: Premeal protein enriched bar
    • Behavioral: Dietary modification
  • Group2
    Dietary modification only
    Intervention: Behavioral: Dietary modification
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sun Joon Moon, MD 82-2-2072-2228 ipleat.m@gmail.com
Contact: Young Min Cho, MD, PhD 82-2-2072-1965 ymchomd@snu.ac.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03727854
Other Study ID Numbers  ICMJE H-1804-120-940
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Young Min Cho, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Young Min Cho, MD, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP