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

NCT01240031 | Unknown

• 1 other identifier: JMS-2010-29293/19069
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malnutrition

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Intake

  Expressed as energy and protein balance (percent of calculated requirements met by intake as per daily dietary recording)

  Study period during admission in hopsital

Secondary Outcomes (3)

• Handgrip strength

  Study period during admission in hopsital

• Reaction time

  Study period during admission in hopsital

• Quality of life

  28 days

Interventions

Individualised nutritional therapy OTHER

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.

Usual nutrition care OTHER

Nutritional therapy according to current practice and general nutrition advice.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead
• Arla Foods: collaborator
• The Danish Dairy Research Foundation, Denmark: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (2)

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

  BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Janice M Sorensen, MSc

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janice M Sorensen, MSc

CONTACT

(+45) 35 33 32 92; janice@life.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 15, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 15, 2010

Record last verified: 2010-11

Locations

DK (1)