NCT01322087

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
Last Updated

March 24, 2011

Status Verified

March 1, 2011

Enrollment Period

4 months

First QC Date

March 17, 2011

Last Update Submit

March 23, 2011

Conditions

Keywords

Nutritionnew energy dense food concept

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Nutritional intervention

EXPERIMENTAL
Dietary Supplement: Nutritional intervention

Interventions

Nutritional interventionDIETARY_SUPPLEMENT

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.

Nutritional intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Terminal patients
  • patients with dysphagia
  • patient with food allergy or intolerance
  • patients who only receives enteral or parenteral nutrition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital at Herlev

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Tina Munk, MSc.

    Copenhagen University Hospital at Herlev

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2011

First Posted

March 24, 2011

Study Start

January 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

March 24, 2011

Record last verified: 2011-03

Locations