Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness
NCT ID: NCT07042087
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2024-11-01
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mindfulness Yoga and Time-Restricted Eating Intervention
Participants in this arm will take part in a 9-month intervention consisting of yoga-based mindfulness sessions combined with time-restricted eating (16:8 protocol). The yoga program includes physical postures (asanas), breathing techniques, and meditation, aimed at improving physical fitness, stress regulation, and cognitive function. The dietary component promotes a flexitarian diet within an 8-hour daily eating window. Sessions are conducted twice weekly for 90 minutes under certified instructors.
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.
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.
Cognitive Training and Stretching Intervention
Participants in this arm will engage in a 9-month intervention including cognitive training exercises and guided stretching. The cognitive program targets multiple domains: verbal and non-verbal memory, executive functions, attention, language, and social cognition. Sessions are delivered twice weekly for 90 minutes by trained therapists. This intervention serves as an active comparator for assessing the effects of yoga and dietary modification on cognitive and biological outcomes.
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.
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
80 Years
ALL
No
Sponsors
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Slovak Academy of Sciences
OTHER_GOV
St. Anne's University Hospital Brno, Czech Republic
OTHER
Responsible Party
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Principal Investigators
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Kateřina Sheardova, MD. PhD.
Role: PRINCIPAL_INVESTIGATOR
The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC)
Locations
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Fnusa/ Icrc
Brno, , Czechia
Countries
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Facility Contacts
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Other Identifiers
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101087124
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
16V/2024
Identifier Type: -
Identifier Source: org_study_id
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