Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness Yoga, Time-Restricted Eating with nutritional counseling promoting a flexitarian dietary pattern, Cognitive Training, Stretching.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease, Aging, Lifestyle Factors, Cognitive Impairment. Basic parameters: 60 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Detailed description
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.
Interventions
- Behavioral 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. - Behavioral 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. - Behavioral 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. - Behavioral 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.
Primary outcome measures
- Composite Score of Cognitive Function [Time frame: Baseline and 9 months]
- Plasma Biomarkers of Neurodegeneration [Time frame: Baseline and 9 months]
Secondary outcome measures (5)
- Computerized Cognitive Test Scores - Cogstate [Time frame: Baseline and 9 months]
- Geriatric depression scale [Time frame: Baseline and 9 months]
- Adherence to Intervention [Time frame: Throughout the 9-month intervention]
- Beck's anxiety inventory [Time frame: Baseline and 9 months]
- Older People's Quality of Life Questionnaire scores [Time frame: Time Frame: Baseline and 9 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Czechia · 1 center
- Fnusa/ Icrc — Brno
Identifiers
NCT: NCT07042087 · 16V/2024 · 101087124