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Идёт набор NCT07466290

L-serine and Strength Training in the Elderly

Без фазы С лечением Brain Health Longevity Cognitive Performance Strength Training Effects

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: Strength training, L-serine supplementation, Control (cornstarch).
Кому может быть актуально
Состояния в реестре: Brain Health, Longevity, Cognitive Performance, Strength Training Effects. Базовые параметры: 65 лет — 85 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
Австрия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This study investigates whether taking the amino acid L-serine, either alone or in combination with targeted strength training, can have a positive effect on mental performance, brain function, and physical fitness in older people. Healthy, independent women and men aged 65 to 85 are eligible to participate. Participants will be randomly assigned to one of three groups: placebo, L-serine, or L-serine combined with strength training. Cognitive tests, physical performance tests, and blood and brain tests will be conducted over a period of 48 weeks. The aim is to gain a better understanding of how nutrition and exercise can contribute to healthy aging.

Подробное описание

The study is a randomized, controlled, double-blind intervention study with three parallel groups of healthy older adults (aged 65-85). It investigates the effects of L-serine supplementation with and without accompanying strength training on cognitive, neural, molecular, and functional parameters over 48 weeks.

The primary endpoint is the change in cognitive performance, measured using the composite RBANS score. Secondary endpoints include structural and functional brain parameters (MRI, EEG), psychosocial parameters, markers of oxidative stress and immune function, as well as physical performance and muscle mass.

Вмешательства

  • Поведенческое Strength training
    Structured strength training 2x/week
  • Пищевая добавка L-serine supplementation
    L-serine supplementation 6g/day
  • Пищевая добавка Control (cornstarch)
    Placebo 6g cornstarch/day, No strength training

Первичные конечные точки

  • Change in cognitive performance measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [Срок оценки: Baseline, 18 weeks and 48 weeks of intervention]
Вторичные конечные точки (12)
  • Change in cognitive domain performance measured by index scores of RBANS [Срок оценки: Baseline, 18 weeks and 48 weeks of intervention]
  • Change in hippocampal volume measured by magnetic resonance imaging (mm³) [Срок оценки: Baseline and 48 weeks of intervention]
  • Change in hippocampal functional connectivity measured by functional magnetic resonance imaging [Срок оценки: Baseline and 48 weeks of intervention]
  • Change in oscillatory brain activity measured using electroencephalography [Срок оценки: Baseline, 18 weeks and 48 weeks of intervention]
  • Change in hippocampal neurometabolite concentrations measured using single voxel magnetic resonance spectroscopy [Срок оценки: Baseline, 18 weeks and 48 weeks of intervention]
  • Change in lower limb muscle strength (isokinetic torque, dominant leg) [Срок оценки: Baseline, 18 weeks and 48 weeks of intervention]
  • Rate of torque development (Nm/s) will be measured at a joint angle of 60 degrees flexion (knee) and 40 degrees flexion (hip). [Срок оценки: Baseline, 18 weeks and 48 weeks of intervention]
  • Change in maximum and total work (J) of knee and hip flexion and extension [Срок оценки: Baseline, 18 weeks and 48 of intervention]
  • Position of peak torque and maximum range of motion (deg.) [Срок оценки: Baseline, 18 weeks and 48 weeks of intervention]
  • Change in time to peak torque and time from peak to relaxation (sec.) during knee and hip extension and flexion [Срок оценки: Baseline, 18 weeks and 48 weeks of intervention]
  • Mean power (W) in knee and hip extension and flexion [Срок оценки: Baseline, 18 weeks, and 48 weeks of intervention]
  • Change in isometric handgrip strength [Срок оценки: Baseline, 18 weeks, and 48 weeks of intervention]

Критерии участия

Критерии включения

  • Men and women between the ages of 65 and 85
  • Mini-Mental-State >23
  • Independently mobile, without aids (walker, cane, etc.)

Критерии исключения

  • Chronic diseases that contraindicate medical training therapy
  • Regular strength training (>1x/week) in the last 6 months before confinement
  • Frailty Index ≥ 3
  • Lack of written consent to test physical performance
  • Regular use of Cortison-containing medications or Antibiotika
  • MR-specific exclusion criteria: claustrophobia, metal equipment or other magnetic Material in or on the body
  • Non-compliance with the study protocol: <70% of the planned L-serine administration, <70% of the strength training

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Австрия · 1 центр
  • NuTraLab — Vienna

Идентификаторы

NCT: NCT07466290 · 01391 · 10.55776/PIN359

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗