Trial Outcomes & Findings for Effect of Premeal Protein-bar on Glycemic Control in Patients With Type 2 Diabetes (NCT NCT03727854)

NCT ID: NCT03727854

Last Updated: 2020-04-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 0 week, 12 weeks
• Results posted on: 2020-04-13

Participant Flow

Participant milestones

Measure	Group1 Premeal protein enriched bar with dietary modification Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). Dietary modification: Subjects in this group will follow diabetes diet education.	Group2 Dietary modification only Dietary modification: Subjects in this group will follow diabetes diet education.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Group1 n=20 Participants Premeal protein enriched bar with dietary modification Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). Dietary modification: Subjects in this group will follow diabetes diet education.	Group2 n=20 Participants Dietary modification only Dietary modification: Subjects in this group will follow diabetes diet education.	Total n=40 Participants Total of all reporting groups
Age, Continuous	64.9 years STANDARD_DEVIATION 5.2 • n=5 Participants	64.1 years STANDARD_DEVIATION 8.3 • n=7 Participants	64.5 years STANDARD_DEVIATION 6.9 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Korean	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 week, 12 weeks

Outcome measures

Measure	Group1 n=20 Participants Premeal protein enriched bar with dietary modification Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). Dietary modification: Subjects in this group will follow diabetes diet education.	Group2 n=20 Participants Dietary modification only Dietary modification: Subjects in this group will follow diabetes diet education.
Change in HbA1c From Baseline	0.015 % (HbA1c) Standard Deviation 0.706	0.030 % (HbA1c) Standard Deviation 0.354

SECONDARY outcome

Timeframe: 0 week, 12 weeks

Outcome measures

Measure	Group1 n=20 Participants Premeal protein enriched bar with dietary modification Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). Dietary modification: Subjects in this group will follow diabetes diet education.	Group2 n=20 Participants Dietary modification only Dietary modification: Subjects in this group will follow diabetes diet education.
Change in Fasting Blood Glucose Level From Baseline	1.9 mg/dL Standard Deviation 26.2	1.6 mg/dL Standard Deviation 25.5

SECONDARY outcome

Timeframe: 0 week, 12 weeks

Outcome measures

Measure	Group1 n=20 Participants Premeal protein enriched bar with dietary modification Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). Dietary modification: Subjects in this group will follow diabetes diet education.	Group2 n=20 Participants Dietary modification only Dietary modification: Subjects in this group will follow diabetes diet education.
Change in Body Weight From Baseline	0.21 kg Standard Deviation 0.98	0.03 kg Standard Deviation 1.26

SECONDARY outcome

Timeframe: 0 week, 12 weeks

Outcome measures

Measure	Group1 n=20 Participants Premeal protein enriched bar with dietary modification Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). Dietary modification: Subjects in this group will follow diabetes diet education.	Group2 n=20 Participants Dietary modification only Dietary modification: Subjects in this group will follow diabetes diet education.
Change in Waist Circumference From Baseline	0.70 cm Standard Deviation 3.73	0.15 cm Standard Deviation 3.15

SECONDARY outcome

Timeframe: 0 week, 12 weeks

Outcome measures

Measure	Group1 n=20 Participants Premeal protein enriched bar with dietary modification Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). Dietary modification: Subjects in this group will follow diabetes diet education.	Group2 n=20 Participants Dietary modification only Dietary modification: Subjects in this group will follow diabetes diet education.
Change in Blood Triglyceride Level From Baseline	-5.05 mg/dL Standard Deviation 50.74	-1.30 mg/dL Standard Deviation 54.21

SECONDARY outcome

Timeframe: 0 week, 12 weeks

Outcome measures

Measure	Group1 n=20 Participants Premeal protein enriched bar with dietary modification Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). Dietary modification: Subjects in this group will follow diabetes diet education.	Group2 n=20 Participants Dietary modification only Dietary modification: Subjects in this group will follow diabetes diet education.
Change in Blood High-density Lipoprotein Level From Baseline	-3.70 mg/dL Standard Deviation 6.38	-5.05 mg/dL Standard Deviation 16.91

SECONDARY outcome

Timeframe: 0 week, 12 weeks

Outcome measures

Measure	Group1 n=20 Participants Premeal protein enriched bar with dietary modification Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). Dietary modification: Subjects in this group will follow diabetes diet education.	Group2 n=20 Participants Dietary modification only Dietary modification: Subjects in this group will follow diabetes diet education.
Change in Blood Low-density Lipoprotein Level From Baseline	2.90 mg/dL Standard Deviation 17.31	-0.70 mg/dL Standard Deviation 20.44

SECONDARY outcome

Timeframe: 0 week, 12 weeks

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.

Outcome measures

Measure	Group1 n=20 Participants Premeal protein enriched bar with dietary modification Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). Dietary modification: Subjects in this group will follow diabetes diet education.	Group2 n=20 Participants Dietary modification only Dietary modification: Subjects in this group will follow diabetes diet education.
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline	-1.00 units Standard Deviation 5.11	-0.46 units Standard Deviation 1.67

SECONDARY outcome

Timeframe: 0 week, 12 weeks

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.

Outcome measures

Measure	Group1 n=20 Participants Premeal protein enriched bar with dietary modification Premeal protein enriched bar: Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day). Dietary modification: Subjects in this group will follow diabetes diet education.	Group2 n=20 Participants Dietary modification only Dietary modification: Subjects in this group will follow diabetes diet education.
Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline	-35.53 units Standard Deviation 196.36	-13.9 units Standard Deviation 58.40

Adverse Events

Group1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor

Seoul National University Hospital

Phone: 82-2-2072-2217

Email: ymchomd@snu.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place