Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06488573

PROgram To Enhance Cardiovascular Risk Trough an Intervention of Nutrition in 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Bipolar Depression Bipolar Disorder Bipolar Disorder (BD) Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritional Intervention

Behavioral

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

Primary outcomes

  1. C reactive protein

    Time frame: Baseline, week 12, week 24 and follow up at week 52

    C reactive protein

  2. Total cholesterol and fractions

    Time frame: Baseline, week 12, week 24 and follow up at week 52

    Total cholesterol and fractions

  3. Glycemia

    Time frame: Baseline, week 12, week 24 and follow up at week 52

    Glycemia

  4. Glycated hemoglobin A1C

    Time frame: Baseline, week 12, week 24 and follow up at week 52

    Glycated hemoglobin A1C

  5. Triglycerides

    Time frame: Baseline, week 12, week 24 and follow up at week 52

    Triglycerides

  6. HOMA IR

    Time frame: Baseline, week 12, week 24 and follow up at week 52

    HOME IR

  7. Apoliporpotein B

    Time frame: Baseline, week 12, week 24 and follow up at week 52

    Apoliporpotein B

  8. 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)

  9. Body weight

    Time frame: Baseline, week 12, week 24 and follow up at week 52

    Body weight

  10. Body fat percentage

    Time frame: Baseline, week 12, week 24 and follow up at week 52

    Body fat percentage

  11. waist circumference

    Time frame: Baseline, week 12, week 24 and follow up at week 52

    waist circumference

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Deakin University

Registry information

Official study title

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

Acronym: PROTECTION-BD

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 5, 2024
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.