The aim of this study is to determine whether the daily use of thickened oral nutritional supplements has an effect on the weight of nursing home residents with dysphagia and (risk for) malnutrition.
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
Synonym
Health condition
dysfagie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in body weight : kg.
Secondary outcome
* Nutritional intake: macro- and micronutrients intake, fluid intake
* Compliance of the study product : % of amount of daily advice of study
product
* General and dysphagia-specific Quality of Life : EQ-5D, Dysphagia Severity
Scale, Dysphagia Quality of Life, Dysphagia Swallowing Anxiety
Background summary
Malnutrition is a common problem among nursing home residents, especially in
residents with dysphagia. Malnutrition may result in detrimental health status
and may impede in activities of daily living. In addition, dysphagia can lead
to pneumonia or dehydration. To date, there are no studies available that have
investigated the effectiveness of pre-thickened ONS on nutritional status in
dysphagic people with or at risk for malnourishment. The current study aims at
investigating the effectiveness of a pre-thickened ONS range on top of standard
nutritional- and dysphagia management on nutritional status in nursing home
residents with dysphagia and (risk for) malnourishment.
Study objective
The aim of this study is to determine whether the daily use of thickened oral
nutritional supplements has an effect on the weight of nursing home residents
with dysphagia and (risk for) malnutrition.
Study design
randomized, controlled, open label- trial
Intervention
pre-thickened oral nutritional supplement
Study burden and risks
For the design of the current study, the guidelines on malnutrition - and
dysphagia management of the Stuurgroep Ondervoeding, the ESPEN and of the Dutch
Association for Throat, Nose and Osteopathy (NVKNO) have been taken into
account. The extra burden of this study to the participants is limited and
neither are there extra risks expected.
It is not possible to conduct this study with competent subjects only since
this group is not representative of the current nursing home population.
Participants will not be exposed to risk proceedings. Blood is taken, though
this is done by knowledgeable and experienced staff. The amount of blood that
is collected does not cause problems in this population.
Universiteitssingel 50
Maastricht 6202 AZ
NL
Universiteitssingel 50
Maastricht 6202 AZ
NL
Listed location countries
Age
Inclusion criteria
1. male or female nursing home resident * 65 years of age
2. diagnosis of (risk on) malnutrition based on the validated short nutritional
assessment questionnaire for residential care (SNAQrc)
3. diagnosis of oropharyngeal dysphagia based on the 90 mL water swallow test
(WST) according to Dutch guidelines and subsequent assessment by speech and
language therapist (SLT)
4. admitted to * or living in a somatic - or psychogeriatric ward in one of the
participating nursing homes
5. written informed consent (IC) from participant or legal representative
Exclusion criteria
- consequent daily use of protein- and/or energy containing ONS in the past 4
weeks
- consequent use of enteral - or parenteral nutrition at the moment of
screening or 4 weeks prior to screening
- investigator*s uncertainty about the willingness or ability of the subject to
comply with the protocol requirements
- known allergy or intolerance to any ingredient of the intervention product,
e.g. lactose intolerance or galactosemia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68301.068.18 |
| Other | zal voordat eerste deelnemer wordt geincludeerd,geregistreerd worden bij trialregister.nl |