Status:
NOT_YET_RECRUITING
PROgram to Enhance Cardiovascular Risk Trough an Intervention of Nutrition in Bipolar Disorder
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Deakin University
Conditions:
Bipolar Depression
Bipolar Disorder (BD)
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Individuals with Bipolar Disorder (BD) have twice the risk of being affected by metabolic comorbidities and a 1.8-fold increased risk of mortality from cardiovascular diseases when compared to the gen...
Eligibility Criteria
Inclusion
- Clinical diagnosis of Bipolar disorder types I and II diagnosis
- Adults of both genders, from 18 to 60 years old
- In typical pharmacotherapy for BD, for at least one month
- Agreement to participate in the study with signature of the consent form
Exclusion
- Patients with "very good or excellent" diet quality assessed by the diet quality scale (ESQUADA): \>275 out of a score of 375
- Patients in a state of hypomania or mania: score \>8 (Young Mania Rating Scale - YMRS)
- Patients with severe depression \>21 Montgomery-Åsberg Depression Rating Scale
- Patients at low cardiovascular risk (\<7 points for men or \<9 points for women on the Framingham Global Risk Score)
- Low weight or eutrophic body mass index: \<25kg/m² as in similar studies
- Pregnant or breastfeeding women
- Patients diagnosed with anorexia and bulimia nervosa
- Patientes diagnosed with Irritable Bowl Syndrome or other diagnosed conditions that affect the gastrointestinal function
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06488573
Start Date
February 1 2026
End Date
December 1 2026
Last Update
March 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fernanda Gabriel
São Paulo, São Paulo, Brazil, 04514102