Randomized Trial:the Effect of Liquid Food on the Intake of Energy and Protein in Malignant Hematologic Patients
Randomized Controlled Trial About the Effect of Liquid Compared to Solid Food on the Intake of Energy and Protein in Patients With Leukemia, Lymphoma or Other Malignant Hematologic Disease
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 25, 2015
CompletedFirst Posted
Study publicly available on registry
May 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedAugust 26, 2016
August 1, 2016
4 months
March 25, 2015
August 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intake of energy and protein
assessed by dietary records from both groups
14 days
Secondary Outcomes (7)
Weightloss change in percent from baseline
14 days
Amount of infections
14 days
Need for tube feeding and parenteral nutrition
14 days
patient satisfaction as well as perception of own nutritional status
14 days
patients compliance of following the nutritional guidelines in the liquid group
14 days
- +2 more secondary outcomes
Study Arms (2)
liquid food
EXPERIMENTALdietary counselling in fulfilling need of protein and energy through liquid food
solid food
OTHERdietary counselling in fulfilling need of protein and energy through solid food
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- not able to cooperate
- need for total tube or parenteral nutrition
- need for dialysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hematological clinic
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jens R Andersen, Lektor
Rigshospitalet, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor at Department of Nutrition, Exercise and Sports, University of Copenhagen
Study Record Dates
First Submitted
March 25, 2015
First Posted
May 18, 2015
Study Start
March 1, 2015
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
August 26, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share