Adding Appetite Stimulants to an ONS in Older Adults

Официальное название

Effects of Adding Appetite Stimulants to a Fibre Containing High-Protein ONS on Appetite-Related Outcomes in Older Adults

Обзор

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)

Вмешательства

• Пищевая добавка Oral nutritional supplement
  During 4 test days, 1 bottle (125ML) of High protein ONS with or without fibre and with or without the added nutrients will be consumed by the subjects. During each test day, the subjects will complete questionnaires related to appetite and liking of the product from baseline (-5 minutes of start consumption of study product) until 120 minutes after start consumption of study product.

Первичные конечные точки

• composite satiety score (CSS) [Срок оценки: 120 minutes]

Вторичные конечные точки (2)

• Satiety after 120 min [Срок оценки: more than 120 minutes]
• Volume consumed [Срок оценки: 120 minutes]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06645184 · 24REX0063741

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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