NCT05518825已完成不适用
Assessment of ONS-flavour Preference in Cancer Patients With and Without Taste Alterations
Nutricia Research1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年10月6日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Choice for the Fortimel/Nutridrink Compact Protein sensation flavour over the Fortimel/Nutridrink Compact Protein regular flavour
研究概览
简要总结
A single arm intervention study examining ONS-flavour preference in cancer patients with and without taste alterations
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with cancer
- •Undergoing, or having undergone systemic anti-cancer treatment or radiotherapy in the past 12 months.
- •Age > 18 years
- •Written informed consent
排除标准
- •Taste and smell alterations not caused by the cancer or anti-cancer treatment
- •Galactosaemia
- •Use of thickener to be able to swallow safely
- •Allergies to any of the product ingredients or any of the flavours
- •Current prescription for ONS, enteral nutrition or parenteral nutrition
- •Diabetes mellitus Type I or Type II
- •Open sores or severe inflammation in the mouth or throat
- •Undergoing dialysis
- •Hepatic encephalopathy
- •Patients with heart failure who have symptoms of heart failure at rest and/or are unable to carry on any physical activity without discomfort
- •Known pregnancy or lactation
- •Average alcohol use of > 21 glasses per week for men or > 14 glasses per week for women or drug abuse in opinion of the investigator
- •Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- •Participation in any other studies involving food products concomitantly or within two weeks prior to entry into the study.
- •Employees of Nutricia Research and/or partners, parents, children and brothers/sisters of employees
研究组 & 干预措施
Fortimel/Nutridrink Compact Protein
Experimental
Twice daily serving of the study product
干预措施: Fortimel/Nutridrink Compact Protein (Dietary Supplement)
结局指标
主要结局
Choice for the Fortimel/Nutridrink Compact Protein sensation flavour over the Fortimel/Nutridrink Compact Protein regular flavour
时间窗: On 4 days
Subjects take one sensation flavour and one regular flavour and are asked in a direct question which flavour they prefer.
次要结局
- Difference between average liking scores [score 0-10] for Fortimel/Nutridrink Compact Protein sensation flavour range versus Fortimel/Nutridrink Compact Protein regular flavour range(On 4 days)
- Choice for the Fortimel/Nutridrink Compact Protein sensation flavours over the Fortimel/Nutridrink Compact Protein regular flavours between patients with and patients without Taste and Smell Alterations(On 4 days)
- Difference in average liking scores [score 0-10] for Fortimel/Nutridrink Compact Protein sensation flavour versus Fortimel/Nutridrink Compact Protein regular flavour between patients with and patients without Taste and Smell Alterations(On 4 days)
研究者
研究点 (1)
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