Trial Outcomes & Findings for COPD: Oral Nutrition Supplements vs. Energy- and Protein Dense in Between Meal Snacks. (NCT NCT02251496)
NCT ID: NCT02251496
Last Updated: 2021-01-19
Results Overview
Weight changes from baseline and one year from admission to the hospital
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
baseline and one year from admission to the hospital
Results posted on
2021-01-19
Participant Flow
Participant milestones
| Measure |
Oral Nutrition Supplement (ONS-group)
The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
Oral nutrition supplement (ONS-group): The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
|
In Between Meals Snacks (Snacks-group)
In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
In between meals snacks (Snacks-group): In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
15
|
|
Overall Study
COMPLETED
|
14
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Oral Nutrition Supplement (ONS-group)
n=19 Participants
The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
Oral nutrition supplement (ONS-group): The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
|
In Between Meals Snacks (Snacks-group)
n=15 Participants
In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
In between meals snacks (Snacks-group): In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=19 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=34 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=19 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=34 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=19 Participants
|
15 Participants
n=15 Participants
|
34 Participants
n=34 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=19 Participants
|
11 Participants
n=15 Participants
|
24 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=19 Participants
|
4 Participants
n=15 Participants
|
10 Participants
n=34 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Iceland
|
19 participants
n=19 Participants
|
15 participants
n=15 Participants
|
34 participants
n=34 Participants
|
|
Weight
|
54 kg
STANDARD_DEVIATION 10 • n=19 Participants
|
49 kg
STANDARD_DEVIATION 10 • n=15 Participants
|
51.4 kg
STANDARD_DEVIATION 9.9 • n=34 Participants
|
|
BMI
|
19.4 kg/m^2
STANDARD_DEVIATION 4.1 • n=19 Participants
|
18.0 kg/m^2
STANDARD_DEVIATION 2.7 • n=15 Participants
|
18.8 kg/m^2
STANDARD_DEVIATION 3.5 • n=34 Participants
|
PRIMARY outcome
Timeframe: baseline and one year from admission to the hospitalWeight changes from baseline and one year from admission to the hospital
Outcome measures
| Measure |
Oral Nutrition Supplement (ONS-group)
n=19 Participants
The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
Oral nutrition supplement (ONS-group): The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
|
In Between Meals Snacks (Snacks-group)
n=15 Participants
In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
In between meals snacks (Snacks-group): In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
|
|---|---|---|
|
Weight Changes
|
2.3 kg
Standard Deviation 4.6
|
4.4 kg
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: baseline and one year from admission to the hospitalSaint George's Respiratory Questionnaire total score (SGRQ) This validated questionnaire is based on 76 items used to calculate three component scores: symptoms, activity and impact, and a total score. A score of 100 represents worst possible health status and a score of 0 represents best possible health status. A change of 4 points in the SGRQ total score is considered the minimum clinically relevant difference.
Outcome measures
| Measure |
Oral Nutrition Supplement (ONS-group)
n=19 Participants
The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
Oral nutrition supplement (ONS-group): The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
|
In Between Meals Snacks (Snacks-group)
n=15 Participants
In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
In between meals snacks (Snacks-group): In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing \~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
|
|---|---|---|
|
Health Related Quality of Life (HRQoL)
|
3.9 score on a scale
Standard Deviation 11.1
|
8.9 score on a scale
Standard Deviation 14.1
|
Adverse Events
Oral Nutrition Supplement (ONS-group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
In Between Meals Snacks (Snacks-group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place