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

Launched by UNIVERSITY OF SAO PAULO · Jun 27, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how changes in diet can help improve heart health for people with Bipolar Disorder (BD). People with BD are at a higher risk for heart problems and other health issues, which can shorten their life expectancy. The study aims to see if a nutrition program, designed by a registered dietitian and based on healthy eating guidelines, can reduce these risks. Participants will be divided into two groups: one will continue their usual treatment, while the other will receive additional support through individual and group sessions focused on nutrition.

To be eligible for the study, participants must be adults aged 18 to 60 with a diagnosis of Bipolar Disorder types I or II and have been receiving standard medication for at least a month. However, those with very good diets or who are currently experiencing severe mood episodes won't be included. Participants can expect to learn about healthy eating habits and how they might positively affect their heart health and overall quality of life. This trial could provide valuable insights into how better food choices can help protect the heart health of individuals with Bipolar Disorder.

Gender

ALL

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