AgingLIBRA-NETNCT06986096
Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention
A study testing Aerobic-strength training and nutritional counseling and Cognitive training and stretching. in people with Aging and Alzheimer Disease, run by Slovak Academy of Sciences at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Aging, Alzheimer Disease, Life Style, Healthy
- What is being tested?
- Aerobic-strength training and nutritional counseling and Cognitive training and stretching.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Sep 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovakia1 site, 1 recruiting
- Recruiting
Biomedical Research Center Slovak Academy of Sciences
Bratislava, Bratislava Region, 84505
Barbara Ukropcova, Prof., +421911643630, barbara.ukropcova@savba.sk
About this study
Official title: Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention, LIBRA-NET
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.
- Conditions
- Aging, Alzheimer Disease, Life Style, Healthy, Exercise, Cognitive Impairment
- Being tested
- Aerobic-strength training and nutritional counseling, Cognitive training and stretching.
- Medical subject headings
- Alzheimer Disease, Motor Activity, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic-strength training and nutritional counselingBehavioural
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.
Cognitive training and stretching.Behavioural
The intervention consists of a structured program that includes cognitive training combined with stretching training (90mins training, 2x per week).
| Study group | Role | What they receive |
|---|---|---|
| Aerobic-strength training and nutritional counseling | Experimental | Elderly volunteers participating in aerobic-strength training and nutritional counseling. Receives: Behavioral: Aerobic-strength training and nutritional counseling |
| Cognitive training and stretching. | Experimental | Elderly volunteers participating in cognitive training combined with stretching training. Receives: Behavioral: Cognitive training and stretching. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on Cognitive Functions
Overall composite score of neuropsychological testing batery (higher score better outcome)
Measured: Measurements at the baseline and after 9-month intervention.
Effect of Interventions on Neurodegeneration Markers
Concentration of plasma neurodegeneration marker pTau 217 (in a subpopulation of patients).
Measured: Measurements at the baseline and after 9-month intervention
Secondary outcomes (7)
Computerized Cognitive Tests
Computerised cognitive testing CogState (learning/working memory score, higher score - better outcome)
Measured: Measurements at the baseline and after 9-month intervention.
Well-being
The World Health Organization Quality of Life questionaire (WHOQOL-BREF), 31 items, highre score better QoL.
Measured: Measurements at the baseline and after 9-month intervention.
Glucose metabolism
oral glucose tolerance test will be perfromed to detect level of glucose intolerance (impaired glucose tolerance)
Measured: Measurements at the baseline and after 9-month intervention.
MRI of the Brain
Imaging studies to assess structural adaptation of the brain (hippocampal volume).
Measured: Measurements at the baseline and after 9-month intervention.
Adherence
Evaluation of participant adherence to the intervention protocol.
Measured: Adherence will be recorded during the 9-month intervention period.
Olfactory Function
Olfactory function screening test (The Sniffin' Sticks test kit).
Measured: Measurements at baseline and after 9-month intervention.
Microbiome Composition
Determination of feacal microbiome composition (16S sequencing).
Measured: Measurements at baseline and after 9-month intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start1 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Slovak Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Barbara Ukropcová, MD, PhD, Slovak Academy of Sciences
- Investigators
- Barbora Ukropcova, Prof., Principal investigator, Biomedical Research Center Slovak Academy of Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06986096
- Sponsor's protocol ID
- 101087124
- Acronym
- LIBRA-NET
- Status last verified
- May 2025
- First submitted
- 15 Jul 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention, LIBRA-NET
- ClinicalTrials.gov ID
- NCT06986096
- Acronym / sponsor ID
- LIBRA-NET / 101087124
- Conditions
- Aging, Alzheimer Disease, Life Style, Healthy, Exercise, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Slovak Academy of SciencesOther government
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic-strength training and nutritional counseling | Experimental | Behavioral: Aerobic-strength training and nutritional counselingElderly volunteers participating in aerobic-strength training and nutritional counseling. |
| Cognitive training and stretching. | Experimental | Behavioral: Cognitive training and stretching.Elderly volunteers participating in cognitive training combined with stretching training. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic-strength training and nutritional counselingThe 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. | Behavioural | Aerobic-strength training and nutritional counseling |
| Cognitive training and stretching.The intervention consists of a structured program that includes cognitive training combined with stretching training (90mins training, 2x per week). | Behavioural | Cognitive training and stretching. |
Primary outcome
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).
7 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbora Ukropcova, Prof. principal investigator
Biomedical Research Center Slovak Academy of Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic-strength training and nutritional counseling and Cognitive training and stretching. in people with Aging and Alzheimer Disease, run by Slovak Academy of Sciences at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbora Ukropcova, Prof. (+421911643630, barbara.ukropcova@sabva.sk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on Cognitive Functions (time frame: Measurements at the baseline and after 9-month intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.