This study evaluates the gastro-intestinal tolerance, nutritional intake, and acceptability of an upgraded composition of an enteral tube feed for adults in need of long term nutritional support.
Four current tube feed products are upgraded with the same product composition and will be investigated in this study. Subjects will be asked to continue with their current tube feeding for 7 days (baseline period) and asked to complete a daily gastro-intestinal tolerance questionnaire. On Day 8, the subjects will switch to one of four upgraded tube feeding products for 14 days (intervention period). The subjects are asked to complete the same gastro-intestinal tolerance questionnaire for again 7 days. On Day 21 (end of intervention), the subjects will return to their original tube feed product and the investigator will follow up on how they are feeling to evaluate tolerability and product acceptability.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
101
Total duration of study: 4 weeks; 1 week on current tube feed followed by 2 weeks on upgraded tube feed comparable in energy density and fiber content as their current tube feed. The tube feeding regimen is similar to pre study feeding regimen. There will then be a one week follow up period.
QClinical
Rotterdam, Netherlands
Gastro-intestinal tolerance
self-reported GI symptoms with a GI symptom questionnaire
Time frame: 7 days in the 1-week baseline period
Gastro-intestinal tolerance
self-reported GI symptoms with a GI symptom questionnaire
Time frame: 7 days in the second week of the 2-week intervention period
bowel movement pattern
Self reported bowel movement pattern with the 7-point Bristol Stool Form Scale (BSFS) ranging from "1" (indicating separate, hard lumps) to "7", which stands for entirely liquid, watery stool without any hard components
Time frame: 7 days in the 1-week baseline period
bowel movement pattern
Self reported bowel movement pattern with the 7-point Bristol Stool Form Scale (BSFS) ranging from "1" (indicating separate, hard lumps) to "7", which stands for entirely liquid, watery stool without any hard components
Time frame: 7 days in the second week of the 2-week intervention period
Volume of tube feed administration
Self reported volume of feed administered
Time frame: 7 days in the 1-week baseline period, 7 days in the first week of the 2-week intervention period, and 7 days in the second week of the 2-week intervention period (i.e., on a daily basis during the entire study duration).
Difference between prescribed volume of tube feed administration by Health Care Professional and actual daily self-reported administrated volume of tube feed
Product compliance
Time frame: 7 days in the 1-week baseline period, 7 days in the first week of the 2-week intervention period, and 7 days in the second week of the 2-week intervention period (i.e., on a daily basis during the entire study duration).
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Use of complementary feeding with a questionnaire ((use of normal foods, oral nutritional supplements, parenteral feeding: Yes/No)
Self reported complementary feeding
Time frame: 7 days in the 1-week baseline period, 7 days in the first week of the 2-week intervention period, and 7 days in the second week of the 2-week intervention period (i.e., on a daily basis during the entire study duration).
Product acceptability with a questionnaire
Self reported product acceptability
Time frame: Day 7 end of baseline period regarding the current tube feed
Product acceptability with a questionnaire
Self reported product acceptability
Time frame: Day 21 (end of intervention period regarding the upgraded tube feed)
Anthropometrics
Body Height (cm)
Time frame: Baseline Day 1
Anthropometrics
Body weight (kg)
Time frame: Baseline Day 1
Anthropometrics
Body weight (kg)
Time frame: Baseline Day 7
Anthropometrics
Body weight (kg)
Time frame: Intervention Day 7
Anthropometrics
Body weight (kg)
Time frame: Intervention Day 14
Anthropometrics
Body weight (kg)
Time frame: Intervention Day 21
Anthropometrics
Body mass index (kg/m\^2)
Time frame: Baseline Day 1
Anthropometrics
Body mass index (kg/m\^2)
Time frame: Baseline Day 7
Anthropometrics
Body mass index (kg/m\^2)
Time frame: Intervention Day 7
Anthropometrics
Body mass index (kg/m\^2)
Time frame: Intervention Day 14
Anthropometrics
Body mass index (kg/m\^2)
Time frame: Intervention Day 21