PROgram To Enhance Cardiovascular Risk Trough an Intervention of Nutrition in Bipolar Disorder (PROTECTION-BD)

February 26, 2026 updated by: Beny Lafer, University of Sao Paulo

The Effect of a Nutritional Intervention Focused on Dietary Pattern in the Cardiovascular Risks of Individuals With Bipolar Disorder

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 04514102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as usual
Experimental: Nutritional intervention
Nutritional intervention based on the Brazilian Dietary Guidelines
Behavioral: Nutritional intervention
7 individual sessions (online) + 6 small group sessions (1-in person + 5 online)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C reactive protein
Time Frame: Baseline, week 12, week 24 and follow up at week 52
C reactive protein
Baseline, week 12, week 24 and follow up at week 52
Total cholesterol and fractions
Time Frame: Baseline, week 12, week 24 and follow up at week 52
Total cholesterol and fractions
Baseline, week 12, week 24 and follow up at week 52
Glycemia
Time Frame: Baseline, week 12, week 24 and follow up at week 52
Glycemia
Baseline, week 12, week 24 and follow up at week 52
Glycated hemoglobin A1C
Time Frame: Baseline, week 12, week 24 and follow up at week 52
Glycated hemoglobin A1C
Baseline, week 12, week 24 and follow up at week 52
Triglycerides
Time Frame: Baseline, week 12, week 24 and follow up at week 52
Triglycerides
Baseline, week 12, week 24 and follow up at week 52
HOMA IR
Time Frame: Baseline, week 12, week 24 and follow up at week 52
HOME IR
Baseline, week 12, week 24 and follow up at week 52
Apoliporpotein B
Time Frame: Baseline, week 12, week 24 and follow up at week 52
Apoliporpotein B
Baseline, week 12, week 24 and follow up at week 52
Cardiovascular risk
Time Frame: Baseline, week 12, week 24 and follow up at week 52
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
Time Frame: Baseline, week 12, week 24 and follow up at week 52
Body weight
Baseline, week 12, week 24 and follow up at week 52
Body fat percentage
Time Frame: Baseline, week 12, week 24 and follow up at week 52
Body fat percentage
Baseline, week 12, week 24 and follow up at week 52
waist circumference
Time Frame: Baseline, week 12, week 24 and follow up at week 52
waist circumference
Baseline, week 12, week 24 and follow up at week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary assessment - dietary intake
Time Frame: Baseline, week 12, week 24 and follow up at week 52
3-day food record from last week (calories and macronutrients)
Baseline, week 12, week 24 and follow up at week 52
Dietary assessment - dietary quality
Time Frame: Baseline, week 12, week 24 and follow up at week 52
ESQUADA (0-375; higher scores mean better outcome)
Baseline, week 12, week 24 and follow up at week 52
Dietary assessment - dietary adehrence
Time Frame: Baseline, week 12, week 24 and follow up at week 52
NUTRINET (0-72; higher scores mean worse outcome)
Baseline, week 12, week 24 and follow up at week 52
Quality of life WHOQOL
Time Frame: Baseline, week 12, week 24 and follow up at week 52
WHOQOL Bref Portuguese (0-100; higher scores mean better outcome)
Baseline, week 12, week 24 and follow up at week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Deakin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 27, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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