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Does the Access to Small Delicious Dishes, Have a Positive Effect on Nutritional Intake in Patients at Nutritional Risk? (SGG)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01322087
First Posted: March 24, 2011
Last Update Posted: March 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Copenhagen University Hospital at Herlev
  Purpose

Rationale:

The objective of this study was to investigate whether a new energy dense food concept, on order 24 hours a day, would lead to a minimum 75% intake of nutritional needs in patients at nutritional risk. The investigators target was for 70% of patients to reach 75% of their energy and protein requirements.

Methods:

An intervention study was conducted with inclusion of 40 patients at nutritional risk, according to the NRS-2002 criteria. The food concept consisted of 36 small delicious dishes. Patients could choose food from both the new concept and the ordinary patient buffet. The investigators monitored patients' nutritional requirements and daily nutritional intake.


Condition Intervention
Malnutrition Dietary Supplement: Nutritional intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Does the Access to Small Delicious Dishes, 24 Hours a Day, Have a Positive Effect on Nutritional Intake in Patients at Nutritional Risk?

Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Change in energy and protein intake compared to the historical control group [ Time Frame: 3 to 7 days recording of dietary intake ]

    The patient's energy requirement was estimated both from the factorial method and by Harris and Benedicts formula and the protein requirements was taken to be 18 E % of the energy requirement.

    Recording of the dietary intake was carried out on a daily basis over a period of 3 to 7 days, with nutritional registration forms filled in by the nurse and/or the patient. The nutritional registration forms contained information of the energy and protein content of the food



Enrollment: 40
Study Start Date: January 2009
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nutritional intervention Dietary Supplement: Nutritional intervention

The study was a 12 weeks intervention trial with inclusion of 40 patients at nutritional risk, according to the NRS-2002 system.

All included patients received nutritional counseling and information about the new food concept by a clinical dietician.

Recording of the dietary intake was carried out on a daily basis over a period of 3 to 7 days, with nutritional registration forms filled in by the nurse and/or the patient.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients at nutritional risk, according to the NRS-2002 criteria.
  • patient must be able to understand the information and be able to give a written inform consent
  • well-functioning gastrointestinal tract
  • Anticipated length of hospitalization > 5 days
  • Should understand and speak danish

Exclusion Criteria:

  • Terminal patients
  • patients with dysphagia
  • patient with food allergy or intolerance
  • patients who only receives enteral or parenteral nutrition
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322087


Locations
Denmark
Copenhagen University Hospital at Herlev
Herlev, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Tina Munk, MSc. Copenhagen University Hospital at Herlev
  More Information

Responsible Party: Michael A. Nielsen, department manager, Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01322087     History of Changes
Other Study ID Numbers: H-D-2008-125
First Submitted: March 17, 2011
First Posted: March 24, 2011
Last Update Posted: March 24, 2011
Last Verified: March 2011

Keywords provided by Copenhagen University Hospital at Herlev:
Nutrition
new energy dense food concept

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders


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