PROgram to Enhance Cardiovascular Risk Trough an Intervention of Nutrition in Bipolar Disorder
- Conditions
- Bipolar DepressionBipolar Disorder (BD)
- Interventions
- Behavioral: Nutritional intervention
- Registration Number
- NCT06488573
- Lead Sponsor
- University of Sao Paulo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 74
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nutritional intervention Nutritional intervention Nutritional intervention based on the Brazilian Dietary Guidelines
- Primary Outcome Measures
Name Time Method C reactive protein Baseline, week 12, week 24 and follow up at week 52 C reactive protein
Glycemia Baseline, week 12, week 24 and follow up at week 52 Glycemia
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
Body weight Baseline, week 12, week 24 and follow up at week 52 Body weight
Apoliporpotein B Baseline, week 12, week 24 and follow up at week 52 Apoliporpotein B
Glycated hemoglobin A1C Baseline, week 12, week 24 and follow up at week 52 Glycated hemoglobin A1C
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)
Total cholesterol and fractions Baseline, week 12, week 24 and follow up at week 52 Total cholesterol and fractions
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
- Secondary Outcome Measures
Name Time Method Dietary assessment - dietary intake Baseline, week 12, week 24 and follow up at week 52 3-day food record from last week (calories and macronutrients)
Quality of life WHOQOL Baseline, week 12, week 24 and follow up at week 52 WHOQOL Bref Portuguese (0-100; higher scores mean better outcome)
Dietary assessment - dietary adehrence Baseline, week 12, week 24 and follow up at week 52 NUTRINET (0-72; higher scores mean worse outcome)
Dietary assessment - dietary quality Baseline, week 12, week 24 and follow up at week 52 ESQUADA (0-375; higher scores mean better outcome)
Trial Locations
- Locations (1)
Fernanda Gabriel
🇧🇷São Paulo, SP, Brazil