Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Stress, Inflammation, Muscle Strength, and Body Composition in Individuals With Down Syndrome
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: Nutrition education, Supplement, Placebo.
- Кому может быть актуально
- Состояния в реестре: Down Syndrome (DS), Supplementation. Базовые параметры: от 18 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
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Purpose: This study will test whether 8 weeks of creatine and HMB supplementation can improve muscle strength, body composition, balance, and overall health in people with Down syndrome. Participants will also receive nutrition tips during the study. Who can participate: People with Down syndrome who can perform basic physical tasks. Must provide consent from the participant and legal guardian. What participants will do: Take creatine (3 g/day) and HMB (3 g/day) or placebo for 8 weeks. Complete tests for muscle strength, balance, and cognitive function. Undergo body composition scans and give blood samples for health markers. Timing: All tests and blood samples are taken before and after each 8-week period. Importance: Results will help determine if creatine and HMB can safely improve strength, balance, and overall health in people with Down syndrome.
Подробное описание
This study is an 8-week randomized, placebo-controlled, crossover trial designed to evaluate the effects of daily supplementation with creatine monohydrate (3 g) and beta-hydroxy-beta-methylbutyrate (HMB, 3 g) on body composition, muscle strength, balance, cognitive function, and biomarkers of oxidative stress and inflammation in individuals with Down syndrome. Participants will receive nutritional education throughout the intervention to support a balanced diet.
Primary outcomes include lean mass measured by dual-energy X-ray absorptiometry (DXA).
Secondary outcomes include fat-free mass (bioimpedance), bone mineral density (DXA), handgrip strength, lower limb strength (Five Times Sit-to-Stand Test), upper and lower body isometric strength (K-Pull test), balance (4-Stage Balance Test), and cognitive function assessed by the Timed Up and Go Dual Task. Blood biomarkers of oxidative stress and inflammation, including reduced glutathione (GSH), superoxide dismutase (SOD), C-reactive protein (CRP), interleukins (IL-1, IL-6, IL-7), and tumor necrosis factor-alpha (TNF-α), will be assessed before and after each supplementation period.
All assessments will be performed at baseline and at the end of each 8-week supplementation phase, allowing for evaluation of both physiological and functional responses to creatine and HMB supplementation in this population.
Вмешательства
- Другое Nutrition education
Participants and their families will also take part in nutrition education sessions to promote healthy eating and lifestyle habits. - Пищевая добавка Supplement
Supplementation with 3 g/day of creatine monohydrate abd 3 g/day of beta-hydroxy-beta-methylbutyrate for 8 weeks - Пищевая добавка Placebo
Supplementation with 6 g/day of inulin orally for 8 weeks
Первичные конечные точки
- Lean mass [Срок оценки: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
Вторичные конечные точки (12)
- Handgrip strength [Срок оценки: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Bone mineral density [Срок оценки: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Reduced glutathione (GSH). [Срок оценки: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- C-reactive protein (CRP) [Срок оценки: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Superoxide dismutase (SOD) activity. [Срок оценки: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Blood levels of interleukins (IL-1, IL-6, IL-7). [Срок оценки: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Tumor necrosis factor-alpha (TNF-α). [Срок оценки: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Fat-free mass [Срок оценки: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Lower limb strength [Срок оценки: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Balance [Срок оценки: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Cognitive function [Срок оценки: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
- Isometric lower body strength [Срок оценки: Baseline (within 2 days before starting supplementation) and at 8 weeks (end of supplementation)]
Критерии участия
Критерии включения
- Diagnosis: Medical confirmation of Down syndrome (trisomy of chromosome 21).
- Physical capacity: Ability to perform basic physical tests (e.g., standing up from a chair or walking without assistance).
- Informed consent: Informed consent will be obtained from both the participant and their legal representative, in compliance with current legislation for individuals requiring support measures.
Критерии исключения
- Chronic kidney disease: Diagnosis of chronic kidney disease.
- Severe motor limitations: Inability to perform the required physical tests (e.g., paralysis or mobility impairments preventing the execution of muscle strength assessments).
- Participation in other studies: Participation in another nutritional or supplementation intervention study within the last 6 months.
- Allergies or intolerances: Known allergy to creatine or to components of the placebo (inulin).
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
- Профилактика
Центры проведения
Испания · 1 центр
- Universidad de Burgos — Burgos
Идентификаторы
NCT: NCT07213063 · CreatineSDown.