RecruitingNot ApplicableNCT07042087

Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness


Sponsor

St. Anne's University Hospital Brno, Czech Republic

Enrollment

48 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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 Criteria10

  • 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

Interventions

BEHAVIORALMindfulness 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.

BEHAVIORALTime-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.

BEHAVIORALCognitive 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.

BEHAVIORALStretching

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.


Locations(1)

Fnusa/ Icrc

Brno, Czechia

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NCT07042087


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