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Effect of Energy- and Protein-rich Foods on Physiological Functions and Quality of Life in Undernourished Patients

NCT ID: NCT01240031

Last Updated: 2010-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-12-31

Brief Summary

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The purpose of this study is to determine whether individualised nutritional therapy comprised of appetising, energy- and protein-rich foods can have a positive effect on physiological function and quality of life of undernourished patients as compared to usual nutrition care.

Detailed Description

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Undernutrition and insufficent dietary intake in hospitalised patients is a widespread problem. It is associated with increased morbidity and mortality, worsened physiological function and quality of life and increased expenses for the health care system. Food quality has been shown to be positively associated with dietary intake in patients. However, there has lacked knowledge on how food quality can be optimised to promote intake. A project was therefore initiated, which aimed at establishing a framework for developing appetising, energy- and protein-rich foods for patients at nutritional risk. This project included qualitative and quantitative investigation of nutritional risk patients' meal experiences and preferences (se citations below). These results have served as a basis for optimsing energy- and protein-rich foods as part of an indivudalised nutritional therapy aimed at improving dietary intake in nutritional risk patients.

Conditions

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Malnutrition

Keywords

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Malnutrition Nutritional Risk Intake Food sensory Nutritional therapy Energy Protein Handgrip strength Reaction time Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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Individualised nutritional therapy

Nutritional therapy as based on previous results of the project on patient meal experiences and preferences (note citations below) and comprising of:

* Thorough sensory and nutrition assessment (questionnaire).
* Nutrition plan adjusted daily according to the assessment.
* Serving appetising, energy- and protein-dense meals, snacks and drinks.

Intervention Type OTHER

Usual nutrition care

Nutritional therapy according to current practice and general nutrition advice.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Nutritional risk as per Nutrition Risk Screening 2002 (NRS-2002)
* Hospital admited at Rigshospitalets (various medical departments)
* Expect length of stay \>= 5 days
* Informed consent to participate

Exclusion Criteria

* Dementia or other psychiatric condition resulting in an inability to give informed consent and to understand study materials.
* Inability to fairly perform the functional measurements (i.e., handgrip strength, reaction time) due to a hand, wrist, arm, shoulder injury or condition.
* Enteral or parenteral nutrition as primary nutritional therapy.
* Previous participation in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arla Foods

INDUSTRY

Sponsor Role collaborator

The Danish Dairy Research Foundation, Denmark

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Department of Human Nutrition, University of Copenhagen

Principal Investigators

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Janice M Sorensen, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Janice M Sorensen, MSc

Role: CONTACT

Phone: (+45) 35 33 32 92

Email: [email protected]

Facility Contacts

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Janice M Sorensen, MSc

Role: primary

References

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Sorensen JM et al. P155 Food sensory issues in nutritional risk patients: an observational, interview-based study. Clin Nutr Suppl 2009;4(2):91.

Reference Type BACKGROUND

Sorensen JM et al. OP004 Food sensory issues in nutritional risk patients: a questionnaire study. Clin Nutr Suppl 2010;5(2):2.

Reference Type BACKGROUND

Other Identifiers

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JMS-2010-29293/19069

Identifier Type: -

Identifier Source: org_study_id