Actively Recruiting
The Effect of a Nutritional Intervention Focused on Dietary Pattern in the Cardiovascular Risks of Individuals With Bipolar Disorder
Led by University of Sao Paulo · Updated on 2026-03-02
88
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo
Lead Sponsor
D
Deakin University
Collaborating Sponsor
AI-Summary
What this Trial Is About
People with Bipolar Disorder BD face higher risks of metabolic problems and heart-related diseases compared to the general population, leading to a shorter life expectancy. This is due to increased inflammation, medication side effects, and common unhealthy lifestyle habits. Nutrition has been helpful in other mental health conditions, but its role in BD is less studied. This research aims to explore how a nutritional approach might affect heart health in people with BD. Participants will be randomly assigned to one of two groups one group will continue their usual treatment, while the other will receive a nutritional intervention based on the Brazilian Dietary Guidelines, delivered by a registered dietitian. This intervention involves seven individual online sessions and six group sessions, one in person and five online. The study will include 72 adults aged 18 to 60 with BD, and the intervention will last through the scheduled visits. Throughout the study, participants will have their heart health monitored through blood tests measuring markers like cholesterol, inflammation, blood sugar, and other cardiovascular risk factors at the start, 12 weeks, 24 weeks, and a follow-up at 52 weeks. Body measurements like weight, body fat, and waist size will also be recorded. Researchers will assess how well participants stick to the diet and how their quality of life changes. The study aims to see if better nutrition can help reduce heart-related risks in people with BD.
CONDITIONS
Brief Title
PROgram To Enhance Cardiovascular Risk Trough an Intervention of Nutrition in Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of Bipolar disorder types I and II
- Adults of both genders, from 18 to 60 years old
- On typical pharmacotherapy for Bipolar Disorder for at least one month
- Agree to participate in the study with signature of the consent form
You will not qualify if you...
- Patients with very good or excellent diet quality assessed by the diet quality scale (ESQUADA) scoring over 275 out of 375
- Patients in a state of hypomania or mania with a score over 8 on the Young Mania Rating Scale (YMRS)
- Patients with severe depression scoring above 21 on the Montgomery-Åsberg Depression Rating Scale
- Patients at low cardiovascular risk (under 7 points for men or under 9 points for women on the Framingham Global Risk Score)
- Low weight or eutrophic body mass index below 25 kg/m²
- Pregnant or breastfeeding women
- Patients diagnosed with anorexia or bulimia nervosa
- Patients diagnosed with Irritable Bowel Syndrome or other conditions affecting gastrointestinal function
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