NCT06645184尚未招募不适用
Effects of Adding Appetite Stimulants to a Fibre Containing High-Protein ONS on Appetite-Related Outcomes in Older Adults
Nutricia Research0 个研究点目标入组 48 人开始时间: 2024年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 主要终点
- composite satiety score (CSS)
研究概览
简要总结
Study to determine whether adding specific nutrients to a high-protein oral nutritional support (ONS), with and without fibre can reduce the feeling of satiety and may increase appetite in adults older than 65 years. This contributes to research into a new type of nutritional nutrition for people with disease related malnutrition (DRM)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participating subjects are blinded and will not know which of the 4 study products they will consume
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 years of age or older
- •Able to consume high energy and/or high protein ONS at discretion of the Investigator
- •Written informed consent
- •Willing and able to refrain from smoking during the visits
- •Able to speak and read in Dutch to communicate with the site staff and comply with the instructions and requirements of the study.
排除标准
- •Any known condition that interferes with the gastric emptying (e.g., gastroparesis, gastric stoma, hypothyroidism, hyperthyroidism, multiple sclerosis, Parkinson disease).
- •Any known metabolic condition that interferes with the breakdown of amino acids (e.g. arginase deficiency, urea cycle disorder)
- •Known history of gastric surgery e.g. (partial) gastrectomy or any other procedure for stomach volume reduction, including gastric banding, gastric balloon.
- •Any known chronic/continuous use, and/or within 24-48h before the visit, of medication that strongly affects with gastric emptying or gastric acid secretion (e.g., metoclopramide, opioid analgesics, calcium channel blockers, Beta-Adrenergic Receptor Agonists, H2 receptor antagonists, proton pump inhibitors; tricyclic antidepressants such as amitriptyline, imipramine, systemic steroids)
- •Known active cancer treatment 4 weeks prior the study start
- •Body Mass Index >= 30.0 kg/m²
- •Presence of Diabetes Mellitus (self-reported or the use of Diabetes medication: i.e., insulin, biguanides, DPP-4 inhibitors, GLP-1 receptor agonists)
- •Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements, for example due to the presence of a psychiatric disorder (e.g. major depression, psychoses), dementia or Alzheimer's disease
- •Known renal dysfunction with protein restriction diet
- •Known allergy to cow's milk protein
- •Known allergy to soy
- •Known galactosaemia
- •Known lactose intolerance
- •Excessive alcohol consumption (use of > 14 units per week for women or > 21 units per week for men, on average during the past 6 months).
- •Drug abuse based on investigator's judgement.
- •Any contraindication to oral feeding per se being: any degree of dysphagia, gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intra-abdominal sepsis.
- •Enrolment in any other studies involving investigational or marketed products concomitantly or within two weeks prior to baseline
- •Employees, family members or other relatives of employees of the participating centre or of Danone Global Research & Innovation Center.
研究组 & 干预措施
ONS with fibre with added nutrients
Other
干预措施: Oral nutritional supplement (Dietary Supplement)
ONS without fiber with added nutrients
Other
干预措施: Oral nutritional supplement (Dietary Supplement)
ONS with fibre without added nutrients
Other
干预措施: Oral nutritional supplement (Dietary Supplement)
ONS without fibre without added nutrients
Other
干预措施: Oral nutritional supplement (Dietary Supplement)
结局指标
主要结局
composite satiety score (CSS)
时间窗: 120 minutes
The main outcome parameter in this study is the composite satiety score (CSS), measured from baseline (-5 minutes) until 120 minutes after starting the consumption of the study product.
次要结局
- Satiety after 120 min(more than 120 minutes)
- Volume consumed(120 minutes)
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