A randomized controlled trial on the effect of pre-thickened oral nutritional supplements on nutritional status of nursing home residents with oropharyngeal dysphagia and (at risk of) malnutritio
- Conditions
- dysfagieundernourishment and swallowing disorder10003018
- Registration Number
- NL-OMON48281
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 156
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in body weight : kg. </p><br>
- Secondary Outcome Measures
Name Time Method <p>* Nutritional intake: macro- and micronutrients intake, fluid intake<br /><br>* Compliance of the study product : % of amount of daily advice of study<br /><br>product<br /><br>* General and dysphagia-specific Quality of Life : EQ-5D, Dysphagia Severity<br /><br>Scale, Dysphagia Quality of Life, Dysphagia Swallowing Anxiety</p><br>