NCT07042087

Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: St. Anne's University Hospital Brno, Czech Republic · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Alzheimer Disease
• Aging
• Lifestyle Factors
• Cognitive Impairment
• Yoga
• Time Restricted Eating
• Diet Modification

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-06-27
• Last updated: 2025-06-27

Locations

1 site across 1 country: Czechia