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

• Sponsor: Jens Rikardt Andersen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02447237
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematological Disease; Delayed Gastric Emptying; Malignant Disease	Other: dietary counselling	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Intake of energy and protein [14 days]

   assessed by dietary records from both groups

Secondary Outcome Measures

1. Weightloss change in percent from baseline [14 days]

   calculated by comparing baseline weight with the weight after 14 days

2. Amount of infections [14 days]

   infection, e.g. fever, diarrhoea will be assessed from the medical record

3. Need for tube feeding and parenteral nutrition [14 days]

   will be assessed from the medical record

4. patient satisfaction as well as perception of own nutritional status [14 days]

   will be assessed from a questionnaire filled out by the patient after completing the intervention

5. patients compliance of following the nutritional guidelines in the liquid group [14 days]

   calculating the amount of energy from liquid food compared to the total energy intake using the dietary records

6. Dose of cytostatics [14 days]

   will be assessed from the medical records

7. unplanned hospital stay [14 days]

   will be assessed from the medical record

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hematological clinic	Copenhagen		Denmark	2100

Sponsors and Collaborators

• Jens Rikardt Andersen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jens Rikardt Andersen, Associate Professor at Department of Nutrition, Exercise and Sports, University of Copenhagen, University of Copenhagen
• ClinicalTrials.gov Identifier: NCT02447237
• Other Study ID Numbers: H-4-2014-113
• First Posted: May 18, 2015
• Last Update Posted: Aug 26, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Jens Rikardt Andersen, Associate Professor at Department of Nutrition, Exercise and Sports, University of Copenhagen, University of Copenhagen: liquid diet; solid diet
• Additional relevant MeSH terms: Gastroparesis; Hematologic Diseases

Study Results

No Results Posted as of Aug 26, 2016