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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02447237
Other study ID # H-4-2014-113
Secondary ID
Status Completed
Phase N/A
First received March 25, 2015
Last updated August 25, 2016
Start date March 2015
Est. completion date July 2015

Study information

Verified date August 2016
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

The study investigates the effect of liquid food on the intake of energy and protein compared to solid food. One group will receive dietary counselling in fulfilling their need for energy and protein from liquid food and the other group from solid food.


Description:

The study investigates the effect of liquid food on the intake of energy and protein compared to solid food. One group will receive dietary counselling in fulfilling their need for energy and protein from liquid food and the other group from solid food. Both groups need to register their dietary intake in a period of 14 days and will be weighed three times during the intervention. At the end of the intervention they need to fill out a questionnaire.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients with leukemia, lymphoma or other malignant hematological disease

- adults

- be able to talk and understand danish

- be able to eat both solid and liquid food

Exclusion Criteria:

- not able to cooperate

- need for total tube or parenteral nutrition

- need for dialysis

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Other:
dietary counselling
the participants will receive dietary counselling in fulfilling their need of energy and protein according to the group they are randomized to (either solid or liquid food).

Locations

Country Name City State
Denmark Hematological clinic Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Jens Rikardt Andersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intake of energy and protein assessed by dietary records from both groups 14 days No
Secondary Weightloss change in percent from baseline calculated by comparing baseline weight with the weight after 14 days 14 days No
Secondary Amount of infections infection, e.g. fever, diarrhoea will be assessed from the medical record 14 days No
Secondary Need for tube feeding and parenteral nutrition will be assessed from the medical record 14 days No
Secondary patient satisfaction as well as perception of own nutritional status will be assessed from a questionnaire filled out by the patient after completing the intervention 14 days No
Secondary patients compliance of following the nutritional guidelines in the liquid group calculating the amount of energy from liquid food compared to the total energy intake using the dietary records 14 days No
Secondary Dose of cytostatics will be assessed from the medical records 14 days No
Secondary unplanned hospital stay will be assessed from the medical record 14 days No
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