Lifestyle for Brain Health — Time-Restricted Eating and Mindfulness
Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness
This 9-month program tests whether combining yoga-based mindfulness with time-restricted eating improves cognition, physical fitness, metabolism, and plasma tau levels in adults 60–80 with subjective or mild cognitive impairment and positive pTau217.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | St. Anne's University Hospital Brno, Czech Republic Academic / other |
| Locations | 1 site (Brno) |
| Trial ID | NCT07042087 on ClinicalTrials.gov |
What this trial studies
This is a randomized two-arm, 9-month intervention comparing mindfulness yoga plus time-restricted eating and nutritional counseling against cognitive training plus stretching in older adults at increased risk for Alzheimer disease. Primary and secondary outcomes include cognitive performance, plasma pTau217 as a marker of neurodegeneration, measures of physical fitness, and metabolic health. The protocol is harmonized with a parallel LIBRA-NET study at Slovak sites so that data from the cognitive-training/stretching arm and some clinical parameters are pooled for joint analysis. The combined approach tests whether lifestyle changes can modify both clinical and biomarker indicators of early neurodegeneration.
Who should consider this trial
Good fit: Adults aged 60–80 with subjective cognitive impairment or mild cognitive impairment, MMSE 24–30, positive plasma pTau217, able to commit to a 9-month program and stable on any cholinesterase inhibitor therapy if applicable.
Not a fit: People with recent stroke or myocardial infarction, unstable or decompensated major medical conditions, active cancer within 5 years, significant neurological or sensory/motor impairments, long-term uncontrolled psychiatric illness, substance abuse, poor anticipated compliance, or unstable dementia medications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could offer a non-drug lifestyle approach to slow cognitive decline and reduce blood markers of neurodegeneration in at-risk older adults.
How similar studies have performed: Individual components—mindfulness/yoga, cognitive training, and time-restricted eating—have shown some cognitive or metabolic benefits in prior studies, but combining these interventions and measuring effects on plasma pTau217 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brno
- Fnusa/ Icrc — Brno, Czechia (Recruiting)
Study contacts
- Principal investigator: Kateřina Sheardova, MD. PhD. — The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.