Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness

N/ARecruitingNCT07042087

St. Anne's University Hospital Brno, Czech Republic48 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alzheimer Disease

Interventions

Mindfulness YogaBEHAVIORAL

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.

Time-Restricted Eating with nutritional counseling promoting a flexitarian dietary patternBEHAVIORAL

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.

Cognitive TrainingBEHAVIORAL

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.

StretchingBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Composite Score of Cognitive Function

Change in composite neuropsychological score from baseline to post-intervention (9 months), including domain-specific scores for memory, executive function/attention, and psychomotor speed.