NL-OMON22842暂停不适用
A randomized controlled trial on the effect of pre-thickened oral nutritional supplements on nutritional status of nursing home residents with dysphagia and (at risk of) malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 156
研究概览
简要总结
Huppertz, V.A.L., van Wijk, N., Baijens, L.W.J. et al. Design of the DYNAMO study: a multi-center randomized controlled trial to investigate the effect of pre-thickened oral nutritional supplements in nursing home residents with dysphagia and malnutrition (risk). BMC Geriatr 20, 537 (2020). https://doi.org/10.1186/s12877-020-01947-4
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.male or female resident = 65 years of age
- •2.diagnosis of malnutrition (risk) based on the validated short nutritional assessment questionnaire for residential care (SNAQ-RC)
- •3.diagnosis of dysphagia based on the 90 mL water swallow test (WST) according to Dutch guidelines and subsequent assessment by the SLT
- •4.admitted to – or living in a somatic - or psychogeriatric ward in one of the participating nursing homes
- •5.written IC from participant or legal representative
排除标准
- •1.consequent daily use of protein- and energy containing ONS in the past 4 weeks
- •2.consequent use of enteral - or parenteral nutrition at the moment of screening or 4 weeks prior to screening
- •3.renal disease requiring dialysis
- •4.residents of which both lower legs were amputated
- •5.investigator’s uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- •6.known allergy or intolerance to any ingredient of the intervention product, e.g. lactose intolerance or galactosemia
- •7.participation in any other study involving investigational or marketed products or care improvement programs within 6 weeks prior to or after randomisation
- •8.known cachexia
研究者
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