Program to lower cardiovascular risk with a nutrition plan for people with bipolar disorder
Official title: The Effect of a Nutritional Intervention Focused on Dietary Pattern in the Cardiovascular Risks of Individuals With Bipolar Disorder
Run by University of Sao Paulo · NCT06488573 · Data updated 2026-11-12
This trial will test whether a dietary program based on the Brazilian Dietary Guidelines can lower cardiovascular risk in adults with bipolar disorder who are on stable medication.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 88 (estimated) |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | April 2026 |
| Main results expected | November 2026 |
| Study ends | December 2027 |
| Registry record updated | March 2, 2026 |
| Trial ID | NCT06488573 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–60 with bipolar I or II on stable pharmacotherapy for at least one month who have moderate or higher cardiovascular risk and do not already have very high diet quality.
✕Probably not a fit
Patients with low cardiovascular risk, a very good/excellent baseline diet, BMI under 25 kg/m², active severe mood episodes, pregnancy/breastfeeding, eating disorders, or major gastrointestinal disorders are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial enrolls adults aged 18–60 with bipolar disorder who are on stable pharmacotherapy and at moderate or higher cardiovascular risk. Participants are randomized to a structured nutritional intervention based on the Dietary Guidelines for the Brazilian population versus usual care, with nutrition counseling and dietary pattern changes as the core components. The main outcomes focus on changes in cardiovascular risk and related metabolic measures (for example, Framingham Global Risk Score and metabolic parameters). Key exclusions include very high baseline diet quality, active mania/hypomania or severe depression, low cardiovascular risk, BMI <25 kg/m², pregnancy or breastfeeding, eating disorders, and gastrointestinal conditions that affect digestion.
Why it matters
Potential benefit: If successful, the intervention could reduce cardiovascular risk and improve metabolic health in people with bipolar disorder, potentially narrowing the mortality gap linked to cardiometabolic disease.
How similar studies have gone: Nutrition-based interventions have shown benefits for metabolic health in other psychiatric populations, but similar randomized interventions specifically in bipolar disorder are limited and relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Fernanda Gabriel
São Paulo, São Paulo, Brazil Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.