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NCT Number: NCT06986096

Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention

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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biomedical Research Center Slovak Academy of Sciences

Bratislava, Bratislava Region, 84505, Slovakia

Location status: Recruiting

Location contact

Barbara Ukropcova, Prof.

CONTACT

[email protected]

+421911643630

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aerobic-strength training and nutritional counseling

Behavioral

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.

Behavioral

The intervention consists of a structured program that includes cognitive training combined with stretching training (90mins training, 2x per week).

Primary outcomes

  1. 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)

  2. 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

  1. Computerized Cognitive Tests

    Time frame: Measurements at the baseline and after 9-month intervention.

    Computerised cognitive testing CogState (learning/working memory score, higher score - better outcome)

  2. Well-being

    Time frame: Measurements at the baseline and after 9-month intervention.

    The World Health Organization Quality of Life questionaire (WHOQOL-BREF), 31 items, highre score better QoL.

  3. Glucose metabolism

    Time frame: Measurements at the baseline and after 9-month intervention.

    oral glucose tolerance test will be perfromed to detect level of glucose intolerance (impaired glucose tolerance)

  4. MRI of the Brain

    Time frame: Measurements at the baseline and after 9-month intervention.

    Imaging studies to assess structural adaptation of the brain (hippocampal volume).

  5. Adherence

    Time frame: Adherence will be recorded during the 9-month intervention period.

    Evaluation of participant adherence to the intervention protocol.

  6. Olfactory Function

    Time frame: Measurements at baseline and after 9-month intervention.

    Olfactory function screening test (The Sniffin' Sticks test kit).

  7. Microbiome Composition

    Time frame: Measurements at baseline and after 9-month intervention.

    Determination of feacal microbiome composition (16S sequencing).

Study contacts

Contact information is provided by the study sponsor or research team.

Barbora Ukropcova, Prof.

CONTACT

[email protected]

+421911643630

Sponsors and collaborators

Lead sponsor

Slovak Academy of Sciences

Other Gov

Registry information

Official study title

Lifestyle for the BRAin Health - Nutrition and Exercise Training Intervention, LIBRA-NET

Acronym: LIBRA-NET

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 22, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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