Randomized Trial:the Effect of Liquid Food on the Intake of Energy and Protein in Malignant Hematologic Patients

August 25, 2016 updated by: Jens Rikardt Andersen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Hematological clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: liquid food
dietary counselling in fulfilling need of protein and energy through liquid food
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).
Other: solid food
dietary counselling in fulfilling need of protein and energy through solid food
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intake of energy and protein
Time Frame: 14 days
assessed by dietary records from both groups
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weightloss change in percent from baseline
Time Frame: 14 days
calculated by comparing baseline weight with the weight after 14 days
14 days
Amount of infections
Time Frame: 14 days
infection, e.g. fever, diarrhoea will be assessed from the medical record
14 days
Need for tube feeding and parenteral nutrition
Time Frame: 14 days
will be assessed from the medical record
14 days
patient satisfaction as well as perception of own nutritional status
Time Frame: 14 days
will be assessed from a questionnaire filled out by the patient after completing the intervention
14 days
patients compliance of following the nutritional guidelines in the liquid group
Time Frame: 14 days
calculating the amount of energy from liquid food compared to the total energy intake using the dietary records
14 days
Dose of cytostatics
Time Frame: 14 days
will be assessed from the medical records
14 days
unplanned hospital stay
Time Frame: 14 days
will be assessed from the medical record
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jens Rikardt Andersen

Investigators

  • Study Director: Jens R Andersen, Lektor, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (Estimate)

May 18, 2015

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2014-113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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