NCT06399250

Brief Summary

The goal of this observational study is to assess food intake in hospitalized patients. The present study will evaluate the impact of a novel in-hospital meal concept (three channel food concept) on total energy and protein intake, macronutrient distribution, and patient appreciation Food intake will be assessed (as part of usual care) by weighing all leftovers (e.g. food that patients did not consume).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 3, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

March 5, 2024

Last Update Submit

April 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • total protein intake

    total protein intake (g/kg/d)

    during hospitalization (minimal 2days max 5days)

Secondary Outcomes (6)

  • total energy intake

    during hospitalization (minimal 2days max 5days)

  • macronutrient intake

    during hospitalization (minimal 2days max 5days)

  • Patient appreciation

    during hospitalization (minimal 2days max 5days)

  • Body weight upon hospital admission

    upon hospital admission

  • Body height upon hospital admission

    upon hospital admission

  • +1 more secondary outcomes

Study Arms (2)

current in-hospital meal service

n=102 patients admitted to the Maastricht University Medical Centre+ (MUMC+) (surgical nursing wards) will be included.

Other: meal service

old in-hospital meal service

This will be an historic control group (data already collected in the past)

Interventions

We're not subjecting patients to an intervention, as we will evaluate the current in-hospital meal service. As the three channel food concept is standard of care, we're not subjecting patients to dietary or behavioral changes. We will compare the data to an historic control.

current in-hospital meal service

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients (\>18y) admitted to surgery nursing wards of the Maastricht University Medical Centre+ (MUMC+).

You may qualify if:

  • \>18y
  • Admitted to surgical nursing wards of MUMC+
  • Expected hospital stay of at least 3 days

You may not qualify if:

  • Receiving (par)enteral nutrition
  • "NPO" (nil per os) policy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Location

MeSH Terms

Conditions

MalnutritionProtein-Energy Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesProtein DeficiencyDeficiency Diseases

Study Officials

  • Luc JC van Loon, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle EG Weijzen, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2024

First Posted

May 3, 2024

Study Start

May 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 3, 2024

Record last verified: 2024-04

Locations