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PROgram To Enhance Cardiovascular Risk Trough an Intervention of Nutrition in Bipolar Disorder

RecruitingNAAges 18 Years - 60 YearsAllUniversity of Sao Paulo
NCT06488573 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 general population. These factors are fundamental in the 14-year reduction in the life expectancy of people with TB reported in recent meta-analyses. This occurs mainly due to the increased inflammation associated with the disease, the adverse effects of pharmacological treatments and unhealthy lifestyle habits that are more common in people diagnosed with BD. Nutrition has been studied as an adjunctive treatment in other psychiatric disorders, but there is a lack of studies about the role of nutrition in TB. Considering that diet can impact metabolic health, this randomized controlled study aims to evaluate the effect of a nutritional intervention on cardiovascular risk in patients with TB. Th

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Nutritional intervention
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Where

1 site
Fernanda Gabriel
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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