NCT03727854

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 27, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
3 months until next milestone

Results Posted

Study results publicly available

April 13, 2020

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

1.3 years

First QC Date

October 31, 2018

Results QC Date

March 18, 2020

Last Update Submit

April 10, 2020

Conditions

Patients With Type 2 Diabetes

Keywords

protein-enriched barglycemic controltype 2 diabeteslong term

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c From Baseline

    0 week, 12 weeks

Secondary Outcomes (8)

  • Change in Fasting Blood Glucose Level From Baseline

    0 week, 12 weeks

  • Change in Body Weight From Baseline

    0 week, 12 weeks

  • Change in Waist Circumference From Baseline

    0 week, 12 weeks

  • Change in Blood Triglyceride Level From Baseline

    0 week, 12 weeks

  • Change in Blood High-density Lipoprotein Level From Baseline

    0 week, 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

Premeal protein group

EXPERIMENTAL

Premeal protein enriched bar with dietary modification

Dietary Supplement: Premeal protein enriched barBehavioral: Dietary modification

Dietary modofication only group

OTHER

Dietary modification only

Behavioral: Dietary modification

Interventions

Premeal protein enriched barDIETARY_SUPPLEMENT

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

Premeal protein group
Dietary modificationBEHAVIORAL

Subjects in this group will follow diabetes diet education.

Dietary modofication only groupPremeal protein group

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Results Point of Contact

Title
Professor
Organization
Seoul National University Hospital
ymchomd@snu.ac.kr
82-2-2072-2217

Study Officials

  • Young Min Cho, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 1, 2018

Study Start

August 27, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 13, 2020

Results First Posted

April 13, 2020

Record last verified: 2020-04

Locations

KR(1)