Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness (LIBRA REMIND)

St. Anne's University Hospital Brno, Czech Republic

Status: Enrolling

Conditions: Aging; Alzheimer Disease; Cognitive Impairment; Time Restricted Eating; Lifestyle Factors; Diet Modification; Yoga

Treatments: Behavioral: Time-Restricted Eating with nutritional counseling promoting a flexitarian dietary pattern; Behavioral: Stretching; Behavioral: Mindfulness Yoga; Behavioral: Cognitive Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07042087

101087124

16V/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Mindfulness Yoga and Time-Restricted Eating Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness Yoga

Behavioral: Time-Restricted Eating with nutritional counseling promoting a flexitarian dietary pattern

Cognitive Training and Stretching Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive Training

Behavioral: Stretching