Fortified Hospital Food as Nutritional Support (DHH)
Positive Effect of Fortified Hospital Food on Nutritional Intake in Patients at Nutritional Risk. A Randomized Controlled Trial.
Background:
The investigators have previously documented that patients at nutritional risk lack sufficient energy and protein intake. In 2009 the investigators conducted a non-randomized historically controlled intervention study of 40 patients at nutritional risk. The study indicated that a tailored food concept increased nutritional intake in this patient group.
The objective of the current study is therefore to investigate these findings in a randomized clinical trial. Our target is for 75% of patients in the intervention group to reach 75% of their energy and protein requirements.
Methods:
The study will compare standard nutritional care (control group) with tailored nutritional care (the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital"). 96 patients at nutritional risk, according to the NRS-2002 criteria, will be included in the study.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Copenhagen
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Herlev, Copenhagen, 덴마크, 2730
- Herlev University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- patients at nutritional risk, according to the NRS-2002 system
- patients must be able to understand the information and be able to give a written informed consent (sufficient cognitive functioning)
- well-functioning gastrointestinal tract
- anticipated length of hospitalization of more than 3 days
Exclusion Criteria:
- terminal patients
- dysphagia
- food allergy or intolerance
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Nutritional intervention
The study will compare standard nutritional care (control group) with tailored nutritional care (the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital")(intervention group).
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The study is af 12 week randomized clinical trail with inclusion of 96 patients at nutritional risk, according to the NRS-2002 system.
The intervention group is is given a tailored nutritional care(the possibility to order small energy and protein-enriched dishes called "Delights of Herlev Hospital").
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements.
기간: Energy and protein intake will be calculated on an average of 3 and up to 7 days of dietary. Number of days of food intake recording depends on how long the patient is hospitalized.
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The patients energy requirement will be estimated both from the factorial method and by Harris and Benedicts formula. Protein requirement will be 18E% of the energy requirement. Recording of the dietary intake will be carried out on a daily basis over a periode of minimum 3 days and maxium 7 days |
Energy and protein intake will be calculated on an average of 3 and up to 7 days of dietary. Number of days of food intake recording depends on how long the patient is hospitalized.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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handgrip strength
기간: at day 3, 5 and 7
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Handgrip strength (HGS)will be measured with a Jamar Digital Hand Dynanometer.
HGS will only be measured in the right hand because the right hand i significantly stronger in right-handed subjects and there is no significant difference between the two sides in left-handed subjects.
Subjects will be encouraged to perform maximal contractions three times with a 15-s interval and the average value will be recorded.
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at day 3, 5 and 7
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average daily energy and protein intake
기간: Patient und energy and protein intake will be followed during hospitalization from enrollment in the study and until discharge or up to 7 days
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Patient und energy and protein intake will be followed during hospitalization from enrollment in the study and until discharge or up to 7 days
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Use of tube feeding
기간: The patients use of tube feeding will be followed from enrollment in the study and until discharge, an expected average of 9 days.
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Use of tube feeding will be registrated (yes or no and amount (ml.)
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The patients use of tube feeding will be followed from enrollment in the study and until discharge, an expected average of 9 days.
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use of parenteral nutrition
기간: The patients use of parenteral nutrition will be followed from enrollment in the study and until discharge, an expected average of 9 days.
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Registration of use of parenteral nutrition (yes or no).
If yes how much (ml.).
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The patients use of parenteral nutrition will be followed from enrollment in the study and until discharge, an expected average of 9 days.
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length of stay
기간: an expected average of 9 days.
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an expected average of 9 days.
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공동 작업자 및 조사자
수사관
- 연구 책임자: Tina Munk, MSc., Herlev University Hospital, Denmark
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- H-1-2011-048
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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