Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness

NCT07042087 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-06-27

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Slovak Academy of Sciences

    collaborator OTHER_GOV
  • St. Anne's University Hospital Brno, Czech Republic

    lead OTHER

Principal Investigators

  • Kateřina Sheardova, MD. PhD. · The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Czechia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07042087 on ClinicalTrials.gov