Trials / Completed
CompletedNCT03727854
Effect of Premeal Protein-bar on Glycemic Control in Patients With Type 2 Diabetes
Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Long-term Glycemic Control in Patients With Type 2 Diabetes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- All
- Age
- 19 Years – 79 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-08-27
- Primary completion
- 2019-12-31
- Completion
- 2019-12-31
- First posted
- 2018-11-01
- Last updated
- 2020-04-13
- Results posted
- 2020-04-13
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03727854. Inclusion in this directory is not an endorsement.