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Lifestyle, Fitness, and Plasma Biomarkers in Healthy Young Adults

Influence of Lifestyle Factors, Cardiorespiratory Fitness, and Body Composition on Plasma BDNF and pTau217 Levels and Cognitive Function in Healthy Young Adults

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07032168
Acronym
NEUROACTIVE
Enrollment
31
Registered
2025-06-22
Start date
2025-06-16
Completion date
2025-10-31
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Young Adults

Keywords

Neuroplasticity, Lifestyle, Healthy young adults, Plasma biomarkers

Brief summary

Lifestyle play a key role in modulating brain health by directly influencing a number of key biological processes, such as neuroplasticity, neurogenesis, and regulation of biomarkers associated with cognitive decline. Factors such as physical activity, diet, sleep quality, stress management, and body composition have been shown to have a significant impact on neuroprotection and cognitive performance. These factors not only contribute to maintaining metabolic and functional balance in the body, but are also linked to the expression of biomarkers such as brain-derived neurotrophic factor (BDNF) and Tau protein phosphorylated at the amino acid threonine 217 (PTau217), which are essential for the maintenance of neuronal health and the prevention of neurodegenerative diseases. In this sense, a healthy lifestyle, characterized by regular physical activity, a balanced diet, good quality sleep, low stress levels and adequate body composition, can act as a protective factor against cognitive decline from early stages of life.

Interventions

None listed

Sponsors

European University Miguel de Cervantes
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes

Inclusion criteria

The following inclusion criteria are established: 1. Age between 18 and 24 years. 2. Not have chronic or neurodegenerative diseases. 3. Not be on pharmacological treatment that affects the central nervous system or metabolism. The

Exclusion criteria

for participants: 1. Medical or traumatological condition that makes it impossible to practice physical exercise. 2. Musculoskeletal injury within 6 months prior to the first visit to the laboratory. 3. Recent surgery (\<3 months). 4. Have a medical condition in which physical activity is contraindicated (assessed with the Physical Activity Predisposition Questionnaire (PARQ+).

Design outcomes

Primary

MeasureTime frameDescription
Plasma biomarkersBaselinePlasma concentrations of BDNF and pTau217 will be assessed using ELISA kits. Fasting venous blood samples will be collected by a qualified nurse from the antecubital vein into EDTA-treated vacutainers and centrifuged at 1500g for 10 minutes. Plasma will then undergo a second centrifugation at 2500g for 15 minutes and be stored in cryogenic vials at -80ºC. BDNF will be measured using the Human/Rat BDNF ELISA Kit (Proteintech Europe; sensitivity: 0.1 pg/mL; range: 12.5-800 pg/mL). PTau217 will be measured using the Human Phosphorylated Tau 217 ELISA Kit (GenoChem World; sensitivity: 0.1 pg/mL; range: 0.8-40 pg/mL).

Secondary

MeasureTime frameDescription
Hip circumferenceBaselineHip circumference will be assed in centimeters (cm)
Waist circumferenceBaselineWaist circumference will be assed in centimeters (cm)
Physical activity levelsDuring one week prior to baselineAn accelerometer (ActiGraph GT3X, Actigraph Corporation, Pensacola, FL) will be provided to all participants one week prior to the assessments to monitor physical activity levels during all waking hours, except during the shower or bath. Registration will take place over a seven-day period, including at least three weekdays (Monday through Friday) and two days during the weekend. The accelerometer will be positioned on the right hip of each participant through the use of an elastic belt. Their position will be reviewed before and after the registration period and participants will be provided with a diary to indicate the hours of use.
Sleep quality and cycle (objective)During one week prior to baselineParticipants will be provided with a Xiaomi® Smart Band 9 activity bracelet to monitor sleep quality. The device will record sleep cycle phases and data, as well as detailed data on heart rate and oxygen saturation.
Sleep quality (subjective)During one week prior to baselineSleep quality will also be assessed by completing the Spanish version of the questionnaire Pittsburgh Sleep Quality Index (PSQI). This questionnaire consists of 24 items, of which 19 questions are self-assessed, while the remaining five are questions assessed by the patient's partner or roommate (the latter are not scored and are used only as clinical information). The total score ranges from 0-21 points, where a higher score indicates a worse subjective quality of sleep.
Heart rate variabilityDuring one week prior to baselineBy monitoring the heart rate of the participants, heart rate variability will be assessed, which involves the variation of the time intervals between beats (R-R intervals) and which is shown to be a useful tool in the control of the patient's health since it is an estimator of the balance between the activity of the sympathetic and parasympathetic autonomic nervous system . To evaluate heart rate variability, a polar H10 band and heart rate monitor (Polar Electro Oy, Kempele, Finland) and a mobile application, specifically Elite HRV will be used. Heart rate variability will be monitored daily for the week prior to the initial assessment visits. To do this, participants will be instructed to take the measurement the first 5 minutes as soon as they wake up and on an empty stomach.
Stress levelsBaselineThe level of perceived stress will be assessed through the perceived stress questionnaire (PSQ). This questionnaire consists of 30 items and is carried out autonomously in the presence of the evaluator (score goes from 0 to 120 points, with higher score indicating more perceived stress levels). In addition, the Perceived Stress Scale (Perceived Stress Scale (PSS)) in its version of 14 items that are carried out in a self-administered way (score goes from 0 to 56, with higher scores indicating more stress levels).
Plasma testosterone/cortisol ratioBaselinePlasma testosterone/cortisol ratio using ELISA kits. Fasting venous blood samples will be collected from the antecubital vein into EDTA-treated vacutainers and centrifuged at 1500g for 10 minutes. Plasma will then undergo a second centrifugation at 2500g for 15 minutes and be stored in cryogenic vials at -80ºC. Sample collection will be performed by a qualified nurse. Testosterone will be measured using the Invitrogen™ High Sensitivity Competitive ELISA Kit (Life Technologies; sensitivity: 2.97 pg/mL; range: 317.0-8440.5 pg/mL). Cortisol will be assessed with the Invitrogen™ Cortisol Competitive ELISA Kit (Life Technologies; sensitivity: 27.6 pg/mL; range: 8.5-23.8 µg/mL).
Nutritional habitsBaselineAdherence to the Mediterranean diet will be assessed through the Mediterranean Diet Quality Index in childhood and adolescence (KIDMED) questionnaire. This quiz It consists of 16 questions that evaluate adherence to this diet in children and young people (from 2 to 24 years old) and can be performed self-administered or conducted by an interviewer. The score goes from -4 to 12, with higher score indicating better adherence to Mediterranean diet.
Handgrip strengthBaselineHandgrip strength will be assessed using the hand-held Jamar® Plus Smart Dynamometer (Patterson Medical Ltd., Sammons Preston, Nottinghamshire, UK). Manual grip strength will be recorded on both limbs and the dynamometer will be adjusted to hand size prior to testing. The participant's elbow should be in 90° flexion and the forearm fully supported on a table.
Gas exchange analysisBaselineThe values of mean and peak gas exchange (ml·kg-1·min-1) during a stress test. The gas analyzer that will be used in this study (Cortex Metalyzer 3B, Leipzig, Germany). The basal metabolic rate (ml·kg-1·min-1) will be determined by recording the variables mentioned above for 15 minutes in supine position.
Cardiovascular responseBaselineThe values of mean and peak heart rate (beats per minute) will be assessed using a polar H10.
Excess Post-exercise Oxygen ConsumptionBaselineThe Excess Post-exercise Oxygen Consumption (EPOC) post-exercise will be recorded on ml·kg-1·min-1. This will be calculated every minute for 12 min after the end of the exercise.
WeightBaselineWeight will be assess on kilograms (kg)
HeightBaselineHeight will be assess on centimeters (cm)
Body surface areaBaselineWeight and height will be combined to report body surface area (BSA) in kg·cm-1
BioimpedanceBaselineThe NUTRILAB bioimpedance device (AKERN Srl, Florence, Italy) will be used. This non-invasive method measures the body's resistance and reactance of the body to the passage of a low-intensity electric current and enables the determination of various body parameters. Bioimpedance provides accurate data on body composition. Users will be instructed to remove all metal-containing objects and remain in a supine position on a couch during the measurements, with the legs in 45° abduction, the shoulders in 30° abduction relative to the center of the body and the hands in pronation. After cleaning the skin with alcohol, two adhesive electrodes (Biatrodes Akern Srl, Florence, Italy) will be placed on the surface of the right hand and two on the right foot. The measurement results will be given in different unit measures depending on the specific variable assessed.
Waist-hip ratioBaselineWill be calculated using the waist circumference (in centimeters) and the hip circumference (in centimeters)
Cognitive performanceBaselineCognitive performance will be assessed through the questionnaire Frontal Assessment Battery (FAB). This questionnaire allows for rapid assessment of executive function through six tests that correspond to each specific cognitive or behavioral domain related to the frontal lobes. The scores ranges from 0 to 18 where higher scores indicating better cognitive function.

Countries

Spain

Contacts

PRINCIPAL_INVESTIGATORSimone Lista, PhD

Miguel de Cervantes European University

STUDY_CHAIRSusana López-Ortiz, PhD

Miguel de Cervantes European University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026