Clinical trial NCT06488573: PROgram to Enhance Cardiovascular Risk Trough an Intervention of Nutrition in Bipolar Disorder
Official title: The Effect of a Nutritional Intervention Focused on Dietary Pattern in the Cardiovascular Risks of Individuals with Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bipolar Depression
Bipolar Disorder (BD)
Keywords: nutrition intervention
nutritional psychiatry
bipolar disorder
dietary intervention
brazilian dietary guideline
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Deakin University
First posted: 2024-07-05
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group vs intervention group
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: C reactive protein
timeFrame: Baseline, week 12, week 24 and follow up at week 52
measure: Total cholesterol and fractions
timeFrame: Baseline, week 12, week 24 and follow up at week 52
measure: Glycemia
timeFrame: Baseline, week 12, week 24 and follow up at week 52
measure: Glycated hemoglobin A1C
timeFrame: Baseline, week 12, week 24 and follow up at week 52
measure: Triglycerides
timeFrame: Baseline, week 12, week 24 and follow up at week 52
measure: HOMA IR
timeFrame: Baseline, week 12, week 24 and follow up at week 52
measure: Apoliporpotein B
timeFrame: Baseline, week 12, week 24 and follow up at week 52
measure: Cardiovascular risk
timeFrame: Baseline, week 12, week 24 and follow up at week 52
measure: Body weight
timeFrame: Baseline, week 12, week 24 and follow up at week 52
measure: Body fat percentage
timeFrame: Baseline, week 12, week 24 and follow up at week 52
measure: waist circumference
timeFrame: Baseline, week 12, week 24 and follow up at week 52
Secondary outcomes:
measure: Dietary assessment - dietary intake
timeFrame: Baseline, week 12, week 24 and follow up at week 52
measure: Dietary assessment - dietary quality
timeFrame: Baseline, week 12, week 24 and follow up at week 52
measure: Dietary assessment - dietary adehrence
timeFrame: Baseline, week 12, week 24 and follow up at week 52
measure: Quality of life WHOQOL
timeFrame: Baseline, week 12, week 24 and follow up at week 52
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Fernanda Gabriel
state: SP
Study officials:
References: