跳至主要内容
临床试验/NL-OMON52167
NL-OMON52167已完成不适用

An exploratory study investigating the effect of adding an appetite stimulant to an ONS on appetite-related outcomes in nursing home residents and in older adults in need of additional nutritional support - Appetite study in nursing homes and older adults needing nutrition

utricia0 个研究点目标入组 17 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
65 至 99(—)

入选标准

  • 1. 65 years of age or older
  • 2. Residing in a nursing home
  • If not residing in a nursing home, in need of additional nutritional support:
  • defined as currently prescribed with oral nutritional supplements (ONS) or
  • being identified as malnourished/at risk of malnutrition based on the MNA-SF.
  • 3. Able to consume high energy and/or high protein ONS at discretion of the
  • Investigator
  • 4. Written informed consent

排除标准

  • 1. Any known gastrointestinal (GI) disease that interferes with the GI motility
  • and nutritional intake, e.g. constipation or diarrhoea secondary to neuropathy,
  • diarrhoea due to chronic inflammatory bowel disease, gastroparesis
  • 2. Any known metabolic condition that interferes with the breakdown of amino
  • acids (e.g. arginase deficiency, urea cycle disorder)
  • 3. Known history of GI surgery (except appendectomy) that interferes with the
  • GI function, e.g. ileostomy, colostomy, (partial) gastrectomy or any other
  • procedure for stomach volume reduction, including gastric banding
  • 4. Investigator*s uncertainty about the willingness or ability of the subject
  • to comply with the protocol requirements, e.g. due to the presence of a
  • psychiatric disorder (e.g. major depression, psychoses), dementia or
  • Alzheimer*s disease
  • 5. Known renal dysfunction (e.g. estimated Glomerular Filtration Rate <30
  • mL/min/1.73 m2)
  • 6. Known allergy to cow*s milk protein
  • 7. Known galactosaemia
  • 8. Known severe lactose intolerance without using lactase
  • 9. Enrolment in any other studies involving investigational or marketed
  • products concomitantly within two weeks prior to baseline

研究者

发起方
utricia

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