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

NCT ID: NCT06488573

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2026-12-31

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.

Conditions

Bipolar Depression; Bipolar Disorder (BD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment as usual

Treatment as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Nutritional intervention

Nutritional intervention based on the Brazilian Dietary Guidelines

Group Type: EXPERIMENTAL

Nutritional intervention

Intervention Type: BEHAVIORAL

7 individual sessions + 8 small group sessions

Interventions

Nutritional intervention

7 individual sessions + 8 small group sessions

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deakin University

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Beny Lafer

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fernanda Gabriel

São Paulo, São Paulo, Brazil

Countries

Brazil

Facility Contacts

FERNANDA GABRIEL, MS

Role: primary

fernandacg.nutri@gmail.com

5511999690790

Other Identifiers

25299

Identifier Type: -

Identifier Source: org_study_id