Clinical trial NCT06986096: Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention
Official title: Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention, LIBRA-NET
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Alzheimer Disease
Life Style, Healthy
Exercise
Cognitive Impairment
Lead sponsor: Slovak Academy of Sciences
Sponsor class: OTHER_GOV
First posted: 2025-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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.

Primary outcomes:
measure: Impact on Cognitive Functions
timeFrame: Measurements at the baseline and after 9-month intervention.
measure: Effect of Interventions on Neurodegeneration Markers
timeFrame: Measurements at the baseline and after 9-month intervention
Secondary outcomes:
measure: Computerized Cognitive Tests
timeFrame: Measurements at the baseline and after 9-month intervention.
measure: Well-being
timeFrame: Measurements at the baseline and after 9-month intervention.
measure: Glucose metabolism
timeFrame: Measurements at the baseline and after 9-month intervention.
measure: MRI of the Brain
timeFrame: Measurements at the baseline and after 9-month intervention.
measure: Adherence
timeFrame: Adherence will be recorded during the 9-month intervention period.
measure: Olfactory Function
timeFrame: Measurements at baseline and after 9-month intervention.
measure: Microbiome Composition
timeFrame: Measurements at baseline and after 9-month intervention.
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Biomedical Research Center Slovak Academy of Sciences
Study officials:
affiliation: Biomedical Research Center Slovak Academy of Science
name: Barbora Ukropcova, Prof.
role: PRINCIPAL_INVESTIGATOR
References: