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NCT Number: NCT02447237

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

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.

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Key information

Conditions

Hematological Disease Delayed Gastric Emptying Digestive System Diseases Gastrointestinal Diseases Gastroparesis Hematologic Diseases Hemic and Lymphatic Diseases Malignant Disease Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hematological clinic

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dietary counselling

Other

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).

Primary outcomes

  1. Intake of energy and protein

    Time frame: 14 days

    assessed by dietary records from both groups

Secondary outcomes

  1. Weightloss change in percent from baseline

    Time frame: 14 days

    calculated by comparing baseline weight with the weight after 14 days

  2. Amount of infections

    Time frame: 14 days

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

  3. Need for tube feeding and parenteral nutrition

    Time frame: 14 days

    will be assessed from the medical record

  4. 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

  5. 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

  6. Dose of cytostatics

    Time frame: 14 days

    will be assessed from the medical records

  7. unplanned hospital stay

    Time frame: 14 days

    will be assessed from the medical record

Sponsors and collaborators

Lead sponsor

Jens Rikardt Andersen

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 18, 2015
Registry last updated
Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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