Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention, LIBRA-NET
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Slovak Academy of Sciences
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Impact on Cognitive Functions
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
ID codes will be provided for the outcomes assessor, without group-specific characterization
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Cognitive training and stretching.
Elderly volunteers participating in cognitive training combined with stretching training.
Intervention: Cognitive training and stretching. (Behavioral)
Aerobic-strength training and nutritional counseling
Elderly volunteers participating in aerobic-strength training and nutritional counseling.
Intervention: Aerobic-strength training and nutritional counseling (Behavioral)
Outcomes
Primary Outcomes
Impact on Cognitive Functions
Time Frame: Measurements at the baseline and after 9-month intervention.
Overall composite score of neuropsychological testing batery (higher score better outcome)
Effect of Interventions on Neurodegeneration Markers
Time Frame: Measurements at the baseline and after 9-month intervention
Concentration of plasma neurodegeneration marker pTau 217 (in a subpopulation of patients).
Secondary Outcomes
- Computerized Cognitive Tests(Measurements at the baseline and after 9-month intervention.)
- Well-being(Measurements at the baseline and after 9-month intervention.)
- Glucose metabolism(Measurements at the baseline and after 9-month intervention.)
- MRI of the Brain(Measurements at the baseline and after 9-month intervention.)
- Adherence(Adherence will be recorded during the 9-month intervention period.)
- Olfactory Function(Measurements at baseline and after 9-month intervention.)
- Microbiome Composition(Measurements at baseline and after 9-month intervention.)
Investigators
Barbara Ukropcová, MD, PhD
Professor
Slovak Academy of Sciences