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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• C reactive protein — Baseline, week 12, week 24 and follow up at week 52
  C reactive protein
• Total cholesterol and fractions — Baseline, week 12, week 24 and follow up at week 52
  Total cholesterol and fractions
• Glycemia — Baseline, week 12, week 24 and follow up at week 52
  Glycemia
• Glycated hemoglobin A1C — Baseline, week 12, week 24 and follow up at week 52
  Glycated hemoglobin A1C
• Triglycerides — Baseline, week 12, week 24 and follow up at week 52
  Triglycerides
• HOMA IR — Baseline, week 12, week 24 and follow up at week 52
  HOME IR
• Apoliporpotein B — Baseline, week 12, week 24 and follow up at week 52
  Apoliporpotein B
• Cardiovascular risk — Baseline, week 12, week 24 and follow up at week 52
  Framingham Global Risk Score (-3 to 21; higher scores mean worse outcome)
• Body weight — Baseline, week 12, week 24 and follow up at week 52
  Body weight
• Body fat percentage — Baseline, week 12, week 24 and follow up at week 52
  Body fat percentage
• waist circumference — Baseline, week 12, week 24 and follow up at week 52
  waist circumference

Trial sites (1)

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