Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness

Обзор

The study aims to evaluate the effects of a 9-month intervention combining yoga-based mindfulness techniques, cognitive training, and nutritional counseling on cognitive function, plasma markers of neurodegeneration (tau protein), physical fitness, and metabolism in older adults at increased risk of developing Alzheimer's disease.

Подробное описание

This randomized two-arm clinical trial aims to evaluate the effects of a 9-month intervention combining yoga-based mindfulness techniques and time-restricted eating (Arm 1) versus cognitive training and stretching (Arm 2) in older adults at increased risk of developing Alzheimer's disease. The study will assess outcomes including cognitive function, plasma biomarkers of neurodegeneration (tau protein), physical fitness, and metabolic health.

The trial is harmonized with the concurrently running LIBRA-NET study (NCT06986096) conducted at Slovak sites (Bratislava and Banská Bystrica). Data from the cognitive training arm and additional clinical parameters will be pooled across both studies for joint statistical analyses. The studies share primary and several secondary outcomes, a shared intervention timeline, assessment protocols, and the cognitive training/stretching arm. The harmonization across all four study sites aims to increase statistical power and enable more generalizable conclusions for a larger population.

Вмешательства

• Поведенческое Mindfulness Yoga
  A structured 9-month program integrating physical yoga postures (asanas), breathing techniques, sound, and meditation. Sessions are conducted twice weekly (90 minutes each) and focus on enhancing physical health, stress regulation, and cognitive performance. Delivered by certified instructors.
• Поведенческое Time-Restricted Eating with nutritional counseling promoting a flexitarian dietary pattern
  Participants follow a 16:8 time-restricted eating schedule (16 hours fasting / 8 hours eating window) for 9 months, with nutritional counseling promoting a flexitarian dietary pattern. The intervention is designed to support metabolic health and reduce risk factors for neurodegeneration.
• Поведенческое Cognitive Training
  A 9-month structured program of twice-weekly cognitive training sessions (90 minutes each), targeting memory, attention, executive function, and social cognition using both paper-based and computer-based tasks. Supervised by trained therapists.
• Поведенческое Stretching
  A twice-weekly stretching routine performed over 9 months (90-minute sessions), led by physiotherapists. This intervention provides low-intensity physical activity to control for physical engagement across study arms.

Первичные конечные точки

• Composite Score of Cognitive Function [Срок оценки: Baseline and 9 months]
• Plasma Biomarkers of Neurodegeneration [Срок оценки: Baseline and 9 months]

Вторичные конечные точки (5)

• Computerized Cognitive Test Scores - Cogstate [Срок оценки: Baseline and 9 months]
• Geriatric depression scale [Срок оценки: Baseline and 9 months]
• Adherence to Intervention [Срок оценки: Throughout the 9-month intervention]
• Beck's anxiety inventory [Срок оценки: Baseline and 9 months]
• Older People's Quality of Life Questionnaire scores [Срок оценки: Time Frame: Baseline and 9 months]

Критерии участия

Критерии включения

• Age 60-80 years
• Diagnosis of Subjective Cognitive Impairment (SCI) or Mild Cognitive Impairment (MCI)
• mini-mental-scale (MMSE) score between 24-30
• Positive plasma pTau217 biomarker
• Stable dose of iAChE therapy (if applicable)
• Ability to participate in a 9-month intervention

Критерии исключения

• Stroke or myocardial infarction within the past year
• Decompensated internal conditions (e.g., severe heart failure, kidney failure, unstable diabetes, GLP1 agonist therapy)
• Long-term psychiatric treatment (except well-managed depression)
• Neurological conditions affecting mobility or cognition (e.g., Parkinson's disease, severe tremor, epilepsy)
• Severe sensory or motor impairment preventing protocol participation
• Active cancer treated within the past 5 years
• Poor anticipated compliance (e.g., transport issues, time constraints, non-cooperation)
• Concurrent participation in another clinical study
• Unstable iAChE medication regimen
• Substance or alcohol dependence

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Чехия · 1 центр

• Fnusa/ Icrc — Brno

Идентификаторы

NCT: NCT07042087 · 16V/2024 · 101087124

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗