Depression
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial. Intervention group: 40 cisgender women aged 18 to 35 years with a body mass index (BMI) between 18.5 and 29.9 kg/m2 (normal weigh
Sponsors
Faculdade de Saúde Pública da Universidade de São Paulo
Faculdade de Saúde Pública da Universidade de São Paulo
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: Cisgender women aged 18 to 35; with a body mass index (BMI) between 18.5 and 29.9 kg/m2 (normal weight and overweight); available to participate in all phases of the study; with regular internet access and a mobile device to communicate with the research team during the study period; who do not have an active diagnosis of psychiatric disorders such as anxiety, depression, and stress, and who consume milk and dairy products daily.
Exclusion criteria
Exclusion criteria: Lactating women; pregnant women; or women in the menopausal period (perimenopause and post-menopause); smokers; those intolerant or allergic to milk and dairy products; those following vegan and/or strict vegetarian diets; those using controlled medications (antidepressants and/or anxiolytics) and supplementing with vitamin D, calcium, or any nutrient with a potential effect on the study outcome up to 3 months prior to the study; those with decompensated metabolic disorders (type II diabetes mellitus, hypertension, and metabolic syndrome); concomitant participation in another clinical trial, and those with an active diagnosis of psychiatric disorders such as anxiety, depression, and stress.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study will be the improvement in mental health, assessed by the change in the total score of the Depression Anxiety Stress Scale – 21 items (DASS-21) between the beginning of the intervention (T0) and the end of the follow-up (T90). The analysis will consider both the total score and the subscales of depression, anxiety, and stress, reflecting the overall response of psychosocial symptoms to the daily consumption of vitamin D-fortified milk. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will include the variation in biochemical markers related to stress, inflammation, and mood regulation, specifically: serotonin, dopamine, cortisol, C-reactive protein (CRP), and 25-hydroxyvitamin D [25(OH)D], measured between T0 and T90. These outcomes aim to complement the clinical assessment, investigating possible physiological mechanisms associated with the intervention, including the impact on neuroendocrine and inflammatory pathways and on vitamin D status. | — |
Countries
Brazil
Contacts
Public ContactElizabeth Torres
Faculdade de Saúde Pública da Universidade de São Paulo
Outcome results
None listed