Pancrelipase With Nutritional Supplement in Patients at Risk of Malnutrition (EFFORT-ENZO)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Zenpep, Placebo.
- Кому может быть актуально
- Состояния в реестре: Malnutrition. Базовые параметры: от 70 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effect of Low Dose Pancrelipase With an Oral Nutritional Supplement to Improve Nutrient Bioavailability in Patients at Increased Risk of Malnutrition
Обзор
This study investigates if pancreatic enzymes in combination with oral nutritional supplement can improve nutrient bioavailability in older people with malnutrition or at risk of malnutrition.
Подробное описание
This study investigates whether adding digestive pancreatic enzymes to oral nutritional supplements (ONS) can improve nutrient absorption in older adults at risk of malnutrition. While ONS are commonly recommended, their effectiveness is often limited due to age-related declines in exocrine pancreatic function, leading to reduced enzyme secretion. Studies indicate that pancreatic lipase levels decline with age, potentially impairing nutrient digestion and absorption.
The study proposes using pancrelipase (Zenpep®), an FDA-approved pancreatic enzyme replacement therapy, to enhance nutrient bioavailability. The randomized, placebo-controlled trial will assess whether pancrelipase improves postprandial levels of amino acids, fatty acids, and glucose in hospitalized patients at nutritional risk.
The study aims to determine if pancreatic enzyme supplementation can enhance nutrient absorption and provide a novel strategy for managing malnutrition in older adults without diagnosed exocrine pancreatic insufficiency (EPI). If successful, this approach could improve clinical outcomes, reduce healthcare costs, and enhance quality of life.
Вмешательства
- Препарат Zenpep
two capsules (each containing 15000 USP units of lipase) together with nutritional supplements - Препарат Placebo
two capsules (containing placebo) together with nutritional supplements
Первичные конечные точки
- Incremental area under the curve of total branched-chained amino acid concentration [Срок оценки: From oral nutritional supplements (ONS) consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)]
Вторичные конечные точки (7)
- Incremental area under the curve of essential amino acids (EAAs) [Срок оценки: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)]
- Incremental area under the curve of total amino acids [Срок оценки: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)]
- Incremental area under the curve of free fatty acids [Срок оценки: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)]
- Incremental area under the curve of triglycerides [Срок оценки: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)]
- Water load satiety test (WLST) [Срок оценки: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)]
- Exploratory subgroup analysis [Срок оценки: After study completion, within 1 year]
- Incremental area under the curve of glucose [Срок оценки: From ONS consumption over 3 hours postprandial, specifically in 5 time points (T0 ONS consumption and after 30, 60, 120 and 180 minutes)]
Критерии участия
Критерии включения
- Informed Consent as documented by signature
- Male or female 70 years of age or older
- Hospitalized at site
- Nutrition Risk Screening 2002 (NRS-2002) ≥ 3
- eGFR ≥ 30 mL/min/1.73 m2 (EPI-CKD) based on medical history (no older than 6 months)
- Ability to eat orally
Критерии исключения
- Patients with acute cardiovascular event ≤ 2 days
- Patients with terminal conditions
- Patients diagnosed with pancreatic exocrine insufficiency (EPI) treated with pancreatic enzyme replacement therapy (PERT)
- Patients having a planned transplant or new-onset dialysis in the next 6 months.
- Patients having a colectomy, resection of the small intestine or cholecystectomy
- Known hypersensitivity to any of the substances or excipients of the ONS or the medicinal product
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Швейцария · 1 центр
- Kantonsspital Aarau — Aarau
Идентификаторы
NCT: NCT06826105 · 2024-02519; ka24Schuetz