Effect of Energy- and Protein-rich Foods on Physiological Functions and Quality of Life in Undernourished Patients
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ClinicalTrials.gov Identifier: NCT01240031 |
Recruitment Status
: Unknown
Verified November 2010 by University of Copenhagen.
Recruitment status was: Recruiting
First Posted
: November 15, 2010
Last Update Posted
: November 15, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malnutrition | Other: Individualised nutritional therapy Other: Usual nutrition care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Framework for Developing Appetising, Energy- and Protein-rich Foods for Patients at Nutritional Risk: Effect on Physiological Functions and Quality of Life |
Study Start Date : | April 2010 |
Estimated Primary Completion Date : | December 2010 |
Estimated Study Completion Date : | December 2010 |

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Other: Individualised nutritional therapy
- Thorough sensory and nutrition assessment (questionnaire).
- Nutrition plan adjusted daily according to the assessment.
- Serving appetising, energy- and protein-dense meals, snacks and drinks.
Nutritional therapy as based on previous results of the project on patient meal experiences and preferences (note citations below) and comprising of:
- Intake [ Time Frame: Study period during admission in hopsital ]Expressed as energy and protein balance (percent of calculated requirements met by intake as per daily dietary recording)
- Handgrip strength [ Time Frame: Study period during admission in hopsital ]Grip track dynamometer (3 trials)
- Reaction time [ Time Frame: Study period during admission in hopsital ]Test for Attentional Performance (TAP version 2, Psytest) Go/NoGo
- Quality of life [ Time Frame: 28 days ]Short Form 36v2 Health Survey (SF36)

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

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): NCT01240031
Contact: Janice M Sorensen, MSc | (+45) 35 33 32 92 | janice@life.ku.dk |
Denmark | |
Rigshospitalet | Recruiting |
Copenhagen, Denmark, 2100 | |
Contact: Janice M Sorensen, MSc (+45) 35 33 32 92 janice@life.ku.dk |
Principal Investigator: | Janice M Sorensen, MSc | University of Copenhagen |
Publications:
Responsible Party: | Janice Marie Sorensen, Department of Human Nutrition, University of Copenhagen |
ClinicalTrials.gov Identifier: | NCT01240031 History of Changes |
Other Study ID Numbers: |
JMS-2010-29293/19069 |
First Posted: | November 15, 2010 Key Record Dates |
Last Update Posted: | November 15, 2010 |
Last Verified: | November 2010 |
Keywords provided by University of Copenhagen:
Malnutrition Nutritional Risk Intake Food sensory Nutritional therapy |
Energy Protein Handgrip strength Reaction time Quality of Life |
Additional relevant MeSH terms:
Malnutrition Nutrition Disorders |