Lifestyle for the BRAin Health - Time Restricted Eating and Mindfulness

NCT07042087 | Recruiting

• 2 other identifiers: 16V/2024101087124
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Alzheimer's Disease Prevention; Mindfulness-Based Intervention; Cognitive Training; Time-Restricted Eating; Dietary consultation

Outcome Measures

Primary Outcomes (2)

• Composite Score of Cognitive Function

  Change in composite neuropsychological score from baseline to post-intervention (9 months), including domain-specific scores for memory, executive function/attention, and psychomotor speed.

  Baseline and 9 months

• Plasma Biomarkers of Neurodegeneration

  Change in concentrations of plasma biomarkers: phosphorylated tau (pTau217, pTau181), GFAP, and neurofilament light chain (NfL).

  Baseline and 9 months

Secondary Outcomes (5)

• Computerized Cognitive Test Scores - Cogstate

  Baseline and 9 months

• Geriatric depression scale

  Baseline and 9 months

• Adherence to Intervention

  Throughout the 9-month intervention

• Beck's anxiety inventory

  Baseline and 9 months

• Older People's Quality of Life Questionnaire scores

  Time Frame: Baseline and 9 months

Study Arms (2)

Mindfulness Yoga and Time-Restricted Eating Intervention

EXPERIMENTAL

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.

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

Cognitive Training and Stretching Intervention

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Training; Behavioral: Stretching

Interventions

Mindfulness Yoga BEHAVIORAL

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.

Mindfulness Yoga and Time-Restricted Eating Intervention

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

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.

Mindfulness Yoga and Time-Restricted Eating Intervention

Cognitive Training BEHAVIORAL

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.

Cognitive Training and Stretching Intervention

Stretching BEHAVIORAL

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.

Cognitive Training and Stretching Intervention

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Anne's University Hospital Brno, Czech Republic: lead
• Slovak Academy of Sciences: collaborator

Study Sites (1)

Fnusa/ Icrc

Brno, 64400, Czechia

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Intermittent Fasting

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kateřina Sheardova, MD. PhD.

  The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 27, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)