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NCT06488573 | NOT YET RECRUITING | Bipolar Depression

PROgram to Enhance Cardiovascular Risk Trough an Intervention of Nutrition in Bipolar Disorder
Sponsor:

University of Sao Paulo

Information provided by (Responsible Party):

Benny of Fake

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.

Condition or disease

Bipolar Depression

Bipolar Disorder (BD)

Intervention/treatment

Nutritional intervention

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 74 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : The Effect of a Nutritional Intervention Focused on Dietary Pattern in the Cardiovascular Risks of Individuals with Bipolar Disorder
Actual Study Start Date : 2026-02
Estimated Primary Completion Date : 2026-08
Estimated Study Completion Date : 2026-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
PROgram to Enhance Cardiovascular Risk Trough an Intervention of Nutrition in Bipolar Disorder

Location Details

NCT06488573

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Locations

Not yet recruiting

Brazil, SP

Fernanda Gabriel

São Paulo, SP, Brazil, 04514102