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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) malnutrition

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) malnutrition - DYNAMO

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48281
Enrollment
156
Registered
2019-07-04
Start date
2019-11-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dysfagie undernourishment and swallowing disorder

Interventions

pre-thickened oral nutritional supplement

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Change in body weight : kg.

Secondary

MeasureTime frame
* 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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)