NCT06488573 PROgram To Enhance Cardiovascular Risk Trough an Intervention of Nutrition in Bipolar Disorder
| NCT ID | NCT06488573 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo |
| Condition | Bipolar Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2026-04 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 88 participants in total. It began in 2026-04 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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. The intervention is based on the dietary pattern recommended in the Dietary Guidelines for the Brazilian Population and will be applied by a registered dietitian. According to the literature, the sample size will be 72 individuals with TB (36 in the control group with usual treatment + 36 in the intervention group added to the usual treatment). The intervention will be carried out in 7 individual sessions and 8 group sessions with specific themes. The primary aim of this protocol will be an intervention to contribute to cardiovascular health - verified by serum markers, anthropometric measurements and the Framingham Cardiovascular Risk Score (algorithm used to estimate an individual's 10-year cardiovascular risk). The secondary stages will be the adherence of the intervention and the impact on the quality of life of the participants. The possible positive results of this nutritional intervention can open new clinical perspectives. Meaning that might show that better food choices can protect the cardiovascular health of individuals with TB, leading to a reduction in morbidity and mortality associated with the disease.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT06488573 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Bipolar Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06488573 currently recruiting?
Yes, NCT06488573 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Sao Paulo to inquire about joining.
Where is the NCT06488573 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06488573 clinical trial?
NCT06488573 is sponsored by University of Sao Paulo. The trial plans to enroll 88 participants.
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