Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorSt. Anne's University Hospital Brno, Czech Republic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Mindfulness Yoga and Time-Restricted Eating InterventionExperimental treatment 2 interventions
Group B: Cognitive Training and Stretching InterventionActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 9 months
2

Plasma Biomarkers of Neurodegeneration

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

Time frame
Baseline and 9 months

Secondary outcomes

1

Computerized Cognitive Test Scores - Cogstate

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

Time frame
Baseline and 9 months
2

Geriatric depression scale

Changes in depression, using the GDS scale

Time frame
Baseline and 9 months
3

Adherence to Intervention

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

Time frame
Throughout the 9-month intervention
4

Beck's anxiety inventory

Anxiety levels measured by the BAI

Time frame
Baseline and 9 months

Other outcomes

Sponsors and contacts

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