---
title: Fortified Hospital Food as Nutritional Support
nct_id: NCT01415635
overall_status: COMPLETED
phase: NA
sponsor: Copenhagen University Hospital at Herlev
study_type: INTERVENTIONAL
primary_condition: Malnutrition
countries: Denmark
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01415635.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01415635"
ct_last_update_post_date: 2012-12-13
last_seen_at: "2026-05-12T06:47:41.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Fortified Hospital Food as Nutritional Support

**Official Title:** Positive Effect of Fortified Hospital Food on Nutritional Intake in Patients at Nutritional Risk. A Randomized Controlled Trial.

**NCT ID:** [NCT01415635](https://clinicaltrials.gov/study/NCT01415635)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 84
- **Lead Sponsor:** Copenhagen University Hospital at Herlev
- **Conditions:** Malnutrition
- **Start Date:** 2011-10
- **Completion Date:** 2012-02
- **CT.gov Last Update:** 2012-12-13

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Nutritional intervention** (EXPERIMENTAL) — 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).

## Interventions

- **Nutritional intervention using** (DIETARY_SUPPLEMENT) — 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").

## Primary Outcomes

- **The primary endpoint was the percentage of patients reaching >75% of their protein and energy requirements.** _(time frame: 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.)_ — 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

## Secondary Outcomes

- **handgrip strength** _(time frame: at day 3, 5 and 7)_
- **average daily energy and protein intake** _(time frame: Patient und energy and protein intake will be followed during hospitalization from enrollment in the study and until discharge or up to 7 days)_
- **Use of tube feeding** _(time frame: The patients use of tube feeding will be followed from enrollment in the study and until discharge, an expected average of 9 days.)_
- **use of parenteral nutrition** _(time frame: The patients use of parenteral nutrition will be followed from enrollment in the study and until discharge, an expected average of 9 days.)_
- **length of stay** _(time frame: an expected average of 9 days.)_

## Locations (1)

- Herlev University Hospital, Herlev, Copenhagen, Denmark

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.herlev university hospital|herlev|copenhagen|denmark` — added _(2026-05-12)_

---

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