The Effect of a Nutritional Intervention Focused on Dietary Pattern in the Cardiovascular Risks of Individuals With Bipolar Disorder
NCT Number: NCT06488573
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bipolar Depression
Interventions: BEHAVIORAL: Nutritional intervention
Sponsor: University of Sao Paulo
Sex: ALL
Age: ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-12
Locations: Fernanda Gabriel, São Paulo, Sp, 04514102, Brazil

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.

Primary Outcome Measures: 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 Outcome Measures: Dietary assessment - dietary intake, 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, ESQUADA (0-375; higher scores mean better outcome), Baseline, week 12, week 24 and follow up at week 52|Dietary assessment - dietary adehrence, NUTRINET (0-72; higher scores mean worse outcome), Baseline, week 12, week 24 and follow up at week 52|Quality of life WHOQOL, WHOQOL Bref Portuguese (0-100; higher scores mean better outcome), Baseline, week 12, week 24 and follow up at week 52