Trial Outcomes & Findings for The Efficacy of Intensive Nutritional Supplement in Patient With Stroke (NCT NCT01810263)

Results Overview

Scale range: 0-100 (higher values represent a better outcome)

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

34 participants

Primary outcome timeframe

6 months

Results posted on

2015-07-02

Participant Flow

* first ever stroke * MRI confirms his/her stroke * weight loss over 2.5% within 2 weeks after the stroke onset * MMSE \>= 10 * medically stable

Participant milestones

Participant milestones
Measure	High Protein Supplement Patients in the both groups keep on routine diet in the hospital All the patients in the High Protein Supplement group were provided additional calories of Nucare(High protein fluid diet, 200kcal/200ml/1 can. Dasang, Seoul, Korea) three times a day. (As a result, additional calories are 600kcal a day)	Control Patients in the both groups keep on routine diet in the hospital. No additional calories are provided.
Overall Study STARTED	16	18
Overall Study COMPLETED	8	11
Overall Study NOT COMPLETED	8	7

Reasons for withdrawal

Reasons for withdrawal
Measure	High Protein Supplement Patients in the both groups keep on routine diet in the hospital All the patients in the High Protein Supplement group were provided additional calories of Nucare(High protein fluid diet, 200kcal/200ml/1 can. Dasang, Seoul, Korea) three times a day. (As a result, additional calories are 600kcal a day)	Control Patients in the both groups keep on routine diet in the hospital. No additional calories are provided.
Overall Study Lost to Follow-up	8	7

Baseline Characteristics

The Efficacy of Intensive Nutritional Supplement in Patient With Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Protein Supplement n=16 Participants high protein supplement given	Control n=18 Participants no intervention	Total n=34 Participants Total of all reporting groups
Age, Continuous	62.8 years STANDARD_DEVIATION 16.0 • n=5 Participants	65.8 years STANDARD_DEVIATION 14.3 • n=7 Participants	64.4 years STANDARD_DEVIATION 15.2 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Korea, Republic of	16 participants n=5 Participants	18 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Scale range: 0-100 (higher values represent a better outcome)

Outcome measures

Outcome measures
Measure	High Protein Supplement n=16 Participants high protein supplement given	Control n=18 Participants no intervention
Modified Barthel Index (MBI) Score at 6 Months	23.3 units on a scale Standard Deviation 2.7	21.9 units on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

Adverse Events

High Protein Supplement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Nam-Jong Paik

Seoul National University Bundang Hospital

Phone: 82-031-787-7731

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place