Developing and Testing Delicious and Nutritious for the Old People

NCT ID: NCT03133364

Last Updated: 2018-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-17

Study Completion Date

2017-08-08

Brief Summary

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Meals-on wheels may play a major role in contributing to better nourishment and quality of life in older people, thus delaying costly hospitalisation. Still, dwelling, old adults who receive meals-on-wheels are a population at risk of undernutrition leading to a decreased quality of life.

Hypothesis Offering nutritious ELDORADO meals as meals-on-wheels to nursing home residents in 3 months is an effective way to increase quality of life.

Aim To improve quality of life and functional abilities in nursing home residents by offering nutritious ELDORADO meals.

Detailed Description

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Intervention The intervention group (n=50) will receive an optimized menu (in both sensory and nutritious aspects) for 12 weeks. In cooperation with the Copenhagen house of food and sensory staff, 19 main meals and 12 between-meals have been optimized based on nursing home residents' evaluations of sensory aspects. On a daily basis the menu will consist of 1 optimized main meal and 1 optimized between-meal, served for dinner. There will be no selective choice for the elderly. If a participant does not want the daily meal, he will receive another meal from the ordinary menu from the kitchen.

Control In comparison, the control group (n=50) will receive the same menu as the intervention group, however, the meals are not optimized on sensory and nutritious aspects. On a daily basis this menu also includes 1 main meal and 1 between-meal in 12 weeks. If a participant does not want the daily meal, he will receive another meal from the ordinary menu from the kitchen.

Conditions

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Quality of Life Nutritional Deficiency Physical Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2-armed randomized controlled study which in total runs 12 weeks.

It has been calculated that 106 participants should be completed. With the risk of loss, 150 elderly are screened and invited to join the study, whereas 120 elderly should be included.

Fifty participants are randomized to receive a control menu for 12 weeks and fifty participants are randomized to receive an intervention menu for 12 weeks.

To enhance subject compliance and avoid treatment group contamination the randomization will be done in "blocks" where each of the 8 departments of the nursing home is randomized to either the Control or Intervention group.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Participants are randomized to the control group (C) and intervention group (I) using the programme "Research randomizer". The main supervisor will manage the randomization.

Participants are blinded to whether they receive the control or intervention menu. Each menu will daily consist of a main meal and a between-meal.

Study Groups

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Sensory optimized meals

Intervention group is receiving:

Popular dishes selected from hospital and meal service menus optimized by sensory experts. Optimization is done with respect to taste, texture and appereance and on nutritional composition of the meals with focus on protein content.

Group Type ACTIVE_COMPARATOR

Sensory optimized meals

Intervention Type OTHER

19 main meals and 12 between-meals are optimized and composed to a menu for 12 weeks.

Control

Control group is receiving:

Popular dishes selected from hospital and meal service menus, NOT optimized by sensory experts.

Group Type PLACEBO_COMPARATOR

Sensory optimized meals

Intervention Type OTHER

19 main meals and 12 between-meals are optimized and composed to a menu for 12 weeks.

Interventions

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Sensory optimized meals

19 main meals and 12 between-meals are optimized and composed to a menu for 12 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Living at Skovhuset, nursing home in Hillerød municipality, Denmark.
* Collecting the "energy-dense diet" "ældrekost" with 40 % fat, with a main meal and a dessert/starter.
* Able to understand and follow instructions for the procedures of the study.
* Above 65 years.

Exclusion Criteria

* Have chewing or swallowing difficulties.
* Have acute disease or acute change in chronic disease.
* Living after special nutritional standards e.g. vegetarian, have any food allergies, or if a participant is excluding common foods from their diet because of other reasons.
* Not able or willing to give informed consent.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Herlev and Gentofte Hospital

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Arne Astrup

Head of institute (Nutrition Exercise and Sports)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Signe Loftager Okkels, Msc

Role: PRINCIPAL_INVESTIGATOR

The Nutrition Research Unit, Gentofte University hospital.

Locations

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Skovhuset, nursing home

Hillerød, , Denmark

Site Status

Countries

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Denmark

References

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Okkels SL, Dybdal DR, Pedersen RJ, Klausen TW, Olsen A, Beck AM, Bugel S. A culinary twist of a two-course meals-on-wheels menu in a cluster-randomized controlled trial influencing health-related quality of life in nursing home residents. Clin Nutr ESPEN. 2021 Jun;43:137-147. doi: 10.1016/j.clnesp.2021.02.002. Epub 2021 Mar 2.

Reference Type DERIVED
PMID: 34024505 (View on PubMed)

Other Identifiers

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H-17002835

Identifier Type: -

Identifier Source: org_study_id

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