Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement

Официальное название

Tolerance and Acceptability Evaluation of AYMES Protein Shot

Обзор

To evaluate the tolerance (gastrointestinal) and acceptability of a new Oral Nutrition Supplement in patients with or at risk of disease related malnutrition, taken either orally or via a feeding tube

Подробное описание

To evaluate tolerance and acceptability of a new Oral Nutrition Supplement in patients with or at risk of malnutrition, who require supplementary nutrition support, either taken orally or with a feeding tube. Outcomes of GI effects, compliance, product preference, convenience etc. will be recorded.

To obtain data to support an ACBS submission (to allow for prescription in the community at NHS expense).

Вмешательства

• Пищевая добавка Shot Style protein supplement
  The Study product is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition.

Первичные конечные точки

• Acceptability and Palatability of Oral Nutrition Supplement [Срок оценки: 28 days]
• Gastro-Intestinal (GI) Tolerance [Срок оценки: 7 days]
• Compliance [Срок оценки: 28 days]

Вторичные конечные точки (1)

• Safety of consumption of Study Product [Срок оценки: 7 days]

Критерии участия

Критерии включения

• Adult patients (≥18 years) who are able to communicate clearly.
• Diagnosis of renal disease or confirmed requirement for protein supplementation by a suitably qualified health care professional (e.g. dietitian)
• Participants with or at risk of malnutrition as determined by the SGA nutritional screening tool, MUST and/or by professional clinical judgement.
• Participants expected to require an ONS for at least 28 days from baseline, to take flavour variants orally and neutral via feeding tube.
• Informed consent obtained.

Критерии исключения

• Participation in any other studies involving investigational or marketed products concomitantly or within seven days prior to entry into the study
• Patients with medical or dietary contraindication to any ingredients (see appendix 2 of protocol for full list.)
• No feeding tube for any patient taking the neutral variant.
• Patients with significant hepatic impairment.
• Patients with dysphagia requiring IDDSI level 1 (or higher) fluids.
• Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
• Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
• Any participant unable to give consent i.e., those with dementia.
• Participants under 18 years of age.
• Individuals who do not have sufficient proficiency with English language
• Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Великобритания · 1 центр

• UCLH NHS Foundation Trust — London

Идентификаторы

NCT: NCT07417514 · AY:PS01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗