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Evaluation of the effects of Magnesium and Inositol Supplementation on sleep quality, Anxiety and quality of life of health students

Evaluation of the effects of Magnesium and Inositol Supplementation on sleep quality, Anxiety and quality of life of health students at a university in southern Brazil: a randomized controlled crossover clinical trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-89c2sqh
Enrollment
Unknown
Registered
2025-10-03
Start date
2024-06-03
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Quality of life

Interventions

This study is a randomized controlled, double-blind crossover clinical trial. A total of 120 medical students from a university in southern Brazil who meet the eligibility criteria will be probabilist

Sponsors

Sociedade de Educação Superior e Cultura Brasil S.A.
Lead Sponsor
Sociedade de Educação Superior e Cultura Brasil S.A.
Collaborator

Eligibility

Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: healthy students; both genders; between 18 and 30 years old; studying medicine; from the University of Southern Santa Catarina; without diagnosed disease and/or under treatment

Exclusion criteria

Exclusion criteria: students with immunosuppressive diseases; oncological diseases; infectious diseases or fever; epileptic diseases; diagnosed with depression, pregnant and/or lactating women, students already taking supplements; with kidney or liver damage; illicit drugs, stimulants, centrally acting medications

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: A reduction in anxiety is expected after the one-month treatment period, as verified by the mean score of the State-Trait Anxiety Inventory (STAI)

Secondary

MeasureTime frame
Expected outcome 2: An improvement in sleep quality is expected after the one-month treatment period, verified by a reduction in the average score on the Pittsburgh questionnaire.;Expected outcome 3: An improvement in quality of life is expected after the one-month treatment period, verified through the reduction in the average score of the Short Form Health Survey 36 (SF-36) questionnaire;Expected outcome 4: An improvement in cortical activation is expected after the one-month treatment period, verified by an increase in the cerebral blood oxygenation rate and cerebral blood flow, measured by the medical equipment called HEG®;Expected outcome 5: An improvement in the activity of the autonomic nervous system is expected after the one-month treatment period, verified through the increase in heart rate variability, measured by the medical equipment called PPG Stress Flow®;Expected outcome 6: It is expected to find an improvement in body composition, after the one-month treatment period, verified through bioimpedance, measured by the medical equipment called BIA-ACC®;Expected outcome 7: An improvement in brain plasticity is expected after the one-month treatment period, as measured by the serum concentration of Brain-Derived Neurotrophic Factor (BDNF);Expected outcome 8: It is expected to find a reduction in oxidative stress parameters, after the one-month treatment period, verified through the decrease in 2',7' dichlorofluorescein (DCF), and improvement in oxidative activity through the increase in the activities of the enzymes catalase (CAT) and superoxide dismutase (SOD);Expected outcome 9: It is expected to find an improvement in mitochondrial function, after the one-month treatment period, verified through the activity of the citrate synthase enzyme, activity of Complex I and II of the electron transport chain

Countries

Brazil

Contacts

Public ContactDaniel Martins

Universidade do Sul de Santa Catarina

danielmartinsfisio@hotmail.com+55-48-999185021

Outcome results

None listed

Source: REBEC (via WHO ICTRP)