Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aerobic-strength training and nutritional counseling, Cognitive training and stretching..
- Who it may be relevant to
- Registry conditions: Aging, Alzheimer Disease, Life Style, Healthy, Exercise. Basic parameters: 60 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovakia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention, LIBRA-NET
Overview
Due to the increasing incidence of dementia and the lack of causal treatment, non-pharmacological interventions represent an attractive and effective therapeutic strategy of neurodegenerative diseases, such as Alzheimer's disease. The aim of the study is to assess the impact of a supervised 9-month intervention with aerobic-strength training and nutritional counseling compared to cognitive training and stretching on the brain, cognitive and motor functions, metabolism, physical fitnes and plasma markers of neurodegenertion in older adults at increased risk of developing Alzheimer's disease.
Interventions
- Behavioral Aerobic-strength training and nutritional counseling
The intervention consists of a structured program that includes aerobic-strength training (1h training, 3 times per week) conducted by professional trainers combined with nutritional counseling. - Behavioral Cognitive training and stretching.
The intervention consists of a structured program that includes cognitive training combined with stretching training (90mins training, 2x per week).
Primary outcome measures
- Impact on Cognitive Functions [Time frame: Measurements at the baseline and after 9-month intervention.]
- Effect of Interventions on Neurodegeneration Markers [Time frame: Measurements at the baseline and after 9-month intervention]
Secondary outcome measures (7)
- Computerized Cognitive Tests [Time frame: Measurements at the baseline and after 9-month intervention.]
- Well-being [Time frame: Measurements at the baseline and after 9-month intervention.]
- Glucose metabolism [Time frame: Measurements at the baseline and after 9-month intervention.]
- MRI of the Brain [Time frame: Measurements at the baseline and after 9-month intervention.]
- Adherence [Time frame: Adherence will be recorded during the 9-month intervention period.]
- Olfactory Function [Time frame: Measurements at baseline and after 9-month intervention.]
- Microbiome Composition [Time frame: Measurements at baseline and after 9-month intervention.]
Eligibility criteria
Inclusion criteria
- Non-smokers
- Signed informed consent
- Presence of subjective or mild cognitive impairment (SCI/aMCI)
- Elevated levels of selected biomarkers confirming the presence of a pathological process characteristic of Alzheimer's disease
- Absence of any psychological, sociological, or geographical factors that could jeopardize participation in the project.
Exclusion criteria
- Presence of severe cardiovascular, liver, or kidney diseases; advanced or poorly controlled diabetes mellitus (HbA1c >7%), treated with insulin or incretin analogs; cancer or any other severe disease as assessed by the responsible physician. A history of cancer treated with chemotherapy or radiotherapy if within less than 5 years post-treatment.
- Lack of cooperation, inflexible schedule, or problematic transportation.
- Insufficient functional capacity or presence of comorbidities that prevent participation in the training program (assessment by an internist, cardiologist, neurologist, orthopedic specialist, or other relevant specialists).
- Presence of a pacemaker or any metal implants (contraindication for MRI examination), or allergy to local anesthetics (contraindication for muscle biopsy).
- Smoking, alcohol dependence, or addiction to other narcotic substances.
- Stroke or myocardial infarction within the last year.
- Long-term treatment for psychiatric disorders - a depressive syndrome is not an exclusion criterion if it is compensated by therapy.
- Other diseases of the musculoskeletal or nervous system that potentially interfere with the ability to exercise or cognition - such as severe arthritis, Parkinson's disease, significant essential tremor, epilepsy, etc.
- Concurrent participation in another clinical study.
- Therapy with cholinesterase inhibitors unless the patient is on a stable dose.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Slovakia · 1 center
- Biomedical Research Center Slovak Academy of Sciences — Bratislava
Identifiers
NCT: NCT06986096 · 101087124