Feasibility Nutritional Supplements for Muscle Growth in CP
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: Dietary Supplement: Leucine.
- Кому может быть актуально
- Состояния в реестре: Spastic Cerebral Palsy. Базовые параметры: 4 лет — 10 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
- Бельгия
- 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
Feasibility Study: Nutritional Supplements to Support Muscle Growth in Children With Cerebral Palsy
Обзор
The purpose of this study is to investigate the feasibility of a 10-week plan with a nutritional supplement (leucine) and to perform pilot analyses on the effect of leucine on macroscopic muscle morphology in children with cerebral palsy.
Подробное описание
Cerebral palsy (CP) is the largest cause of childhood physical disability, with a prevalence of 2 to 3 per 1000 live births. While the disorder is caused by a non-progressive lesion in the developing brain, musculoskeletal alterations progress with age. The observed neuromuscular symptoms mainly involve spasticity and muscle weakness. Macroscopic lower limb muscle properties in CP, i.e. reduced muscle volume, length, anatomical cross-sectional area (CSA), and fiber CSA, have been reported, providing convincing evidence for impaired muscle growth in children with CP, already at young ages. Nutritional supplements may improve muscle strength and cause muscle hypertrophy. Within the muscle, protein synthesis depends on the availability of the branched chain amino acids (BCAA), and mainly on the presence of leucine. This stimulatory effect is thought to be primarily mediated by the upregulation of mRNA translation via enhanced signaling through the mTOR pathway. BCAA or leucine supplements have been widely used to improve muscle strength and achieve hypertrophy. In paediatric CP groups, such muscular effect of nutritional supplementation on macroscopic intrinsic muscle properties (i.e. muscle volume, anatomical CSA and muscle belly length) has not yet been studied. Therefore, a feasibility study will be carried out to investigate the feasibility of a 10-week plan with a nutritional supplement (leucine) and to perform pilot analyses on the effect of leucine on macroscopic muscle morphology in five children with cerebral palsy. This feasibility study will provide proof of concept of the administration plan of the leucine supplement and of the study design. Additionally, it will provide data for power analyses, that will be used in a future comprehensive study, investigating the effect of leucine on macroscopic muscle properties in children with cerebral palsy. To cover safety issues blood and urine sampling will be performed to objectify the patient's nutritional state and to exclude underlying disorders that would contraindicate the use of protein supplements.
Вмешательства
- Пищевая добавка Dietary Supplement: Leucine
150mg/kg body mass/day
Первичные конечные точки
- Patient adherence to the nutritional supplements [Срок оценки: Between the start and the end of the 10-week nutritional plan.]
- Overall changes in muscle volume of the medial gastrocnemius [Срок оценки: At the start and the end of the 10-week nutritional plan]
- Overall changes in muscle length of the medial gastrocnemius [Срок оценки: At the start and the end of the 10-week nutritional plan]
- Overall changes in muscle cross-sectional area at 50% of muscle belly length [Срок оценки: At the start and the end of the 10-week nutritional plan]
- Overall changes in echo-intensity of the medial gastrocnemius [Срок оценки: At the start and the end of the 10-week nutritional plan]
Вторичные конечные точки (3)
- Functional strength test [Срок оценки: At the start and the end of the 10-week nutritional plan]
- 3-day food record [Срок оценки: Before the start of the 10-week nutritional plan]
- Global body composition [Срок оценки: At the start and the end of the 10-week nutritional plan]
Критерии участия
Критерии включения
Spastic Cerebral Palsy (diagnosed by a neuro-pediatrician from the CP Reference Centre of the University Hospital Leuven)
- Uni- of bilateral involvement
- Level II or III on the Gross Motor Function Classification System (GMFCS)
- Muscle volume for the medial gastrocnemius (target muscle) of at least 20% compared to the expected muscle volume in age-matched typically developing children
Критерии исключения
- Presence of dyskinesia or ataxia
- Severe co-morbidities
- Botulinum toxin treatment ten months prior to assessment
- Previous orthopedic or neurosurgery
- Severe ankle deformities preventing fitting in test positions
- Ankle range of motion (ROM) <30% of normal values
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
- Лечение
Центры проведения
Бельгия · 1 центр
- UZ Leuven — Leuven
Идентификаторы
NCT: NCT06044168 · S66961