Lifestyle, Fitness, and Plasma Biomarkers in Healthy Young Adults

NCT07032168 | Completed

• 1 other identifier: PI-DOC010-NEUROACTIVE
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Young Adults

Keywords

Neuroplasticity; Lifestyle; Healthy young adults; Plasma biomarkers

Outcome Measures

Primary Outcomes (1)

• Plasma biomarkers

  Plasma 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).

  Baseline

Secondary Outcomes (19)

• Physical activity levels

  During one week prior to baseline

• Sleep quality and cycle (objective)

  During one week prior to baseline

• Waist-hip ratio

  Baseline

• Hip circumference

  Baseline

• Waist circumference

  Baseline

Study Arms (1)

Healthy young adults

Healthy young adults (18-24 years old)

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy young adults, between 18 and 24 years old.

You may qualify if:

• Age between 18 and 24 years.
• Not have chronic or neurodegenerative diseases.
• Not be on pharmacological treatment that affects the central nervous system or metabolism.

You may not qualify if:

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

Sponsors & Collaborators

• European University Miguel de Cervantes: lead

Study Sites (1)

Miguel de Cervantes European University

Valladolid, Valladolid, 47012, Spain

Location

Related Publications (10)

• Hurtado-Pomares M, Juarez-Leal I, Company-Devesa V, Sanchez-Perez A, Peral-Gomez P, Espinosa-Sempere C, Valera-Gran D, Navarrete-Munoz EM. Psychometric properties of the Spanish version of the Frontal Assessment Battery (FAB-E) and normative values in a representative adult population sample. Neurologia (Engl Ed). 2024 Oct;39(8):694-700. doi: 10.1016/j.nrleng.2022.09.004. Epub 2022 Oct 7.

  PMID: 36216225 RESULT

• Benito PJ, Alvarez-Sanchez M, Diaz V, Morencos E, Peinado AB, Cupeiro R, Maffulli N; PRONAF Study Group. Cardiovascular Fitness and Energy Expenditure Response during a Combined Aerobic and Circuit Weight Training Protocol. PLoS One. 2016 Nov 10;11(11):e0164349. doi: 10.1371/journal.pone.0164349. eCollection 2016.

  PMID: 27832062 RESULT

• Jarvinen L, Lundin Petersdotter S, Chaillou T. High-intensity resistance exercise is not as effective as traditional high-intensity interval exercise for increasing the cardiorespiratory response and energy expenditure in recreationally active subjects. Eur J Appl Physiol. 2022 Feb;122(2):459-474. doi: 10.1007/s00421-021-04849-4. Epub 2021 Nov 19.

  PMID: 34799752 RESULT

• Perrotta AS, Jeklin AT, Hives BA, Meanwell LE, Warburton DER. Validity of the Elite HRV Smartphone Application for Examining Heart Rate Variability in a Field-Based Setting. J Strength Cond Res. 2017 Aug;31(8):2296-2302. doi: 10.1519/JSC.0000000000001841.

  PMID: 28195974 RESULT

• Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

  PMID: 8598068 RESULT

• Concheiro-Moscoso P, Groba B, Alvarez-Estevez D, Miranda-Duro MDC, Pousada T, Nieto-Riveiro L, Mejuto-Muino FJ, Pereira J. Quality of Sleep Data Validation From the Xiaomi Mi Band 5 Against Polysomnography: Comparison Study. J Med Internet Res. 2023 May 19;25:e42073. doi: 10.2196/42073.

  PMID: 37204853 RESULT

• Klein AB, Williamson R, Santini MA, Clemmensen C, Ettrup A, Rios M, Knudsen GM, Aznar S. Blood BDNF concentrations reflect brain-tissue BDNF levels across species. Int J Neuropsychopharmacol. 2011 Apr;14(3):347-53. doi: 10.1017/S1461145710000738. Epub 2010 Jul 7.

  PMID: 20604989 RESULT

• Poo MM. Neurotrophins as synaptic modulators. Nat Rev Neurosci. 2001 Jan;2(1):24-32. doi: 10.1038/35049004.

  PMID: 11253356 RESULT

• Gomez-Pinilla F, Tyagi E. Diet and cognition: interplay between cell metabolism and neuronal plasticity. Curr Opin Clin Nutr Metab Care. 2013 Nov;16(6):726-33. doi: 10.1097/MCO.0b013e328365aae3.

  PMID: 24071781 RESULT

• Walsh R. Lifestyle and mental health. Am Psychol. 2011 Oct;66(7):579-92. doi: 10.1037/a0021769.

  PMID: 21244124 RESULT

Study Officials

• Simone Lista, PhD

  Miguel de Cervantes European University

  PRINCIPAL INVESTIGATOR

• Susana López-Ortiz, PhD

  Miguel de Cervantes European University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 22, 2025
• Study Start: June 16, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)