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Diet coaching may cut heart risk in bipolar patients

NCT ID NCT06488573

Disease control Sponsor: University of Sao Paulo Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

People with bipolar disorder face double the risk of heart disease and die 14 years earlier on average. This study tests whether a personalized nutrition program—based on Brazil's dietary guidelines—can improve heart health markers like cholesterol, blood sugar, and body fat. Eighty-eight adults with bipolar disorder will either receive usual care or add 13 nutrition sessions over several months. The goal is to see if better eating habits can lower inflammation and cardiovascular risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nutritional counseling based on Brazilian Dietary Guidelines
What this could lead to
If it works, this could show that better food choices protect heart health in people with bipolar disorder, potentially reducing early death from heart disease.
What could go wrong
This is a small, early-stage trial (88 people) testing a behavioral change, not a drug. Results may not apply broadly, and diet adherence can be challenging.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 88 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bipolar depression bipolar disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar depression Bipolar disorder (BD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fernanda Gabriel

    RECRUITING

    São Paulo, São Paulo, 04514102, Brazil

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