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

Malnutrition Clinical Trial

— SGG  

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322087
• Other study ID #: H-D-2008-125
• Status: Completed
• Phase: N/A
• First received: March 17, 2011
• Last updated: March 23, 2011
• Start date: January 2009
• Est. completion date: May 2009

Study information

• Verified date: March 2011
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malnutrition

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.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital at Herlev	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in energy and protein intake compared to the historical control group	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	3 to 7 days recording of dietary intake	No