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

NCT06488573 | Recruiting

• 1 other identifier: 25299
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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)

Keywords

nutrition intervention; nutritional psychiatry; bipolar disorder; dietary intervention; brazilian dietary guideline

Outcome Measures

Primary Outcomes (11)

• C reactive protein

  C reactive protein

  Baseline, week 12, week 24 and follow up at week 52

• Total cholesterol and fractions

  Total cholesterol and fractions

  Baseline, week 12, week 24 and follow up at week 52

• Glycemia

  Glycemia

  Baseline, week 12, week 24 and follow up at week 52

• Glycated hemoglobin A1C

  Glycated hemoglobin A1C

  Baseline, week 12, week 24 and follow up at week 52

• Triglycerides

  Triglycerides

  Baseline, week 12, week 24 and follow up at week 52

• HOMA IR

  HOME IR

  Baseline, week 12, week 24 and follow up at week 52

• Apoliporpotein B

  Apoliporpotein B

  Baseline, week 12, week 24 and follow up at week 52

• Cardiovascular risk

  Framingham Global Risk Score (-3 to 21; higher scores mean worse outcome)

  Baseline, week 12, week 24 and follow up at week 52

• Body weight

  Body weight

  Baseline, week 12, week 24 and follow up at week 52

• Body fat percentage

  Body fat percentage

  Baseline, week 12, week 24 and follow up at week 52

• waist circumference

  waist circumference

  Baseline, week 12, week 24 and follow up at week 52

Secondary Outcomes (4)

• Dietary assessment - dietary intake

  Baseline, week 12, week 24 and follow up at week 52

• Dietary assessment - dietary quality

  Baseline, week 12, week 24 and follow up at week 52

• Dietary assessment - dietary adehrence

  Baseline, week 12, week 24 and follow up at week 52

• Quality of life WHOQOL

  Baseline, week 12, week 24 and follow up at week 52

Study Arms (2)

Treatment as usual

NO INTERVENTION

Treatment as usual

Nutritional intervention

EXPERIMENTAL

Nutritional intervention based on the Brazilian Dietary Guidelines

Behavioral: Nutritional intervention

Interventions

Nutritional intervention BEHAVIORAL

7 individual sessions (online) + 6 small group sessions (1-in person + 5 online)

Nutritional intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Deakin University: collaborator

Study Sites (1)

Fernanda Gabriel

São Paulo, São Paulo, 04514102, Brazil

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Model Details: Control group vs intervention group

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: July 5, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

BR (1)