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NCT Number: NCT07042087

Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness

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.

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Key information

Conditions

Alzheimer Disease Aging Behavior Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Diet Modification Fasting Feeding Behavior Intermittent Fasting Lifestyle Factors Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies Time Restricted Eating Yoga

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fnusa/ Icrc

Brno, 64400, Czechia

Location status: Recruiting

Location contact

Kateřina Sheardova, MD. PhD.

PRINCIPAL_INVESTIGATOR

Kurečková Kurečková, Ing.

CONTACT

[email protected]

+420 54 318 4086

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Yoga

Behavioral

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 pattern

Behavioral

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 training

Behavioral

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.

Stretching

Behavioral

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 outcomes

  1. Composite Score of Cognitive Function

    Time frame: Baseline and 9 months

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

  2. Plasma Biomarkers of Neurodegeneration

    Time frame: Baseline and 9 months

    Change in concentrations of plasma biomarkers: phosphorylated tau (pTau217, pTau181), GFAP, and neurofilament light chain (NfL).

Secondary outcomes

  1. Computerized Cognitive Test Scores - Cogstate

    Time frame: Baseline and 9 months

    Change in individual and composite scores on computerized cognitive tests (e.g., Cogstate), including measures of spatial orientation.

  2. Geriatric depression scale

    Time frame: Baseline and 9 months

    Changes in depression, using the GDS scale

  3. Adherence to Intervention

    Time frame: Throughout the 9-month intervention

    Attendance rate and adherence to prescribed intervention protocol (minimum attendance threshold and dietary compliance).

  4. Beck's anxiety inventory

    Time frame: Baseline and 9 months

    Anxiety levels measured by the BAI

  5. Older People's Quality of Life Questionnaire scores

    Time frame: Time Frame: Baseline and 9 months

    Quality of life measured by OPQOL-35

Sponsors and collaborators

Lead sponsor

St. Anne's University Hospital Brno, Czech Republic

Other

Collaborators

  • Slovak Academy of Sciences

Registry information

Acronym: LIBRA REMIND

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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