Bipolar DepressionPROTECTION-BDNCT06488573
PROgram To Enhance Cardiovascular Risk Trough an Intervention of Nutrition in Bipolar Disorder
A study testing Nutritional intervention in people with Bipolar Depression and Bipolar Disorder (BD), run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Depression, Bipolar Disorder (BD)
- What is being tested?
- Nutritional intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Fernanda Gabriel
São Paulo, São Paulo, 04514102
FERNANDA GABRIEL, MS, 5511999690790, fernandacg.nutri@gmail.com
About this study
Official title: The Effect of a Nutritional Intervention Focused on Dietary Pattern in the Cardiovascular Risks of Individuals With Bipolar Disorder
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.
- Conditions
- Bipolar Depression, Bipolar Disorder (BD)
- Being tested
- Nutritional intervention
- Keywords
- nutrition intervention, nutritional psychiatry, bipolar disorder, dietary intervention, brazilian dietary guideline
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional interventionBehavioural
7 individual sessions (online) + 6 small group sessions (1-in person + 5 online)
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Treatment as usual |
| Nutritional intervention | Experimental | Nutritional intervention based on the Brazilian Dietary Guidelines Receives: Behavioral: Nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
C reactive protein
C reactive protein
Measured: Baseline, week 12, week 24 and follow up at week 52
Total cholesterol and fractions
Total cholesterol and fractions
Measured: Baseline, week 12, week 24 and follow up at week 52
Glycemia
Glycemia
Measured: Baseline, week 12, week 24 and follow up at week 52
Glycated hemoglobin A1C
Glycated hemoglobin A1C
Measured: Baseline, week 12, week 24 and follow up at week 52
Triglycerides
Triglycerides
Measured: Baseline, week 12, week 24 and follow up at week 52
HOMA IR
HOME IR
Measured: Baseline, week 12, week 24 and follow up at week 52
Apoliporpotein B
Apoliporpotein B
Measured: Baseline, week 12, week 24 and follow up at week 52
Cardiovascular risk
Framingham Global Risk Score (-3 to 21; higher scores mean worse outcome)
Measured: Baseline, week 12, week 24 and follow up at week 52
Body weight
Body weight
Measured: Baseline, week 12, week 24 and follow up at week 52
Body fat percentage
Body fat percentage
Measured: Baseline, week 12, week 24 and follow up at week 52
waist circumference
waist circumference
Measured: Baseline, week 12, week 24 and follow up at week 52
Secondary outcomes (4)
Dietary assessment - dietary intake
3-day food record from last week (calories and macronutrients)
Measured: Baseline, week 12, week 24 and follow up at week 52
Dietary assessment - dietary quality
ESQUADA (0-375; higher scores mean better outcome)
Measured: Baseline, week 12, week 24 and follow up at week 52
Dietary assessment - dietary adehrence
NUTRINET (0-72; higher scores mean worse outcome)
Measured: Baseline, week 12, week 24 and follow up at week 52
Quality of life WHOQOL
WHOQOL Bref Portuguese (0-100; higher scores mean better outcome)
Measured: Baseline, week 12, week 24 and follow up at week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study startApr 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group vs intervention group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Deakin University
- Responsible party
- Principal investigator, Beny Lafer, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488573
- Sponsor's protocol ID
- 25299
- Acronym
- PROTECTION-BD
- Status last verified
- Feb 2026
- First submitted
- 17 Jun 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Nutritional Intervention Focused on Dietary Pattern in the Cardiovascular Risks of Individuals With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT06488573
- Acronym / sponsor ID
- PROTECTION-BD / 25299
- Conditions
- Bipolar Depression, Bipolar Disorder (BD)
- Keywords
- nutrition intervention, nutritional psychiatry, bipolar disorder, dietary intervention, brazilian dietary guideline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Deakin University
- Study start
- Apr 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Control group vs intervention group
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –Treatment as usual |
| Nutritional intervention | Experimental | Behavioral: Nutritional interventionNutritional intervention based on the Brazilian Dietary Guidelines |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional intervention7 individual sessions (online) + 6 small group sessions (1-in person + 5 online) | Behavioural | Nutritional intervention |
Primary outcome
C reactive protein
Time frame: Baseline, week 12, week 24 and follow up at week 52
C reactive protein
Total cholesterol and fractions
Time frame: Baseline, week 12, week 24 and follow up at week 52
Total cholesterol and fractions
Glycemia
Time frame: Baseline, week 12, week 24 and follow up at week 52
Glycemia
Glycated hemoglobin A1C
Time frame: Baseline, week 12, week 24 and follow up at week 52
Glycated hemoglobin A1C
Triglycerides
Time frame: Baseline, week 12, week 24 and follow up at week 52
Triglycerides
HOMA IR
Time frame: Baseline, week 12, week 24 and follow up at week 52
HOME IR
Apoliporpotein B
Time frame: Baseline, week 12, week 24 and follow up at week 52
Apoliporpotein B
Cardiovascular risk
Time frame: Baseline, week 12, week 24 and follow up at week 52
Framingham Global Risk Score (-3 to 21; higher scores mean worse outcome)
Body weight
Time frame: Baseline, week 12, week 24 and follow up at week 52
Body weight
Body fat percentage
Time frame: Baseline, week 12, week 24 and follow up at week 52
Body fat percentage
waist circumference
Time frame: Baseline, week 12, week 24 and follow up at week 52
waist circumference
4 secondary outcomes
Dietary assessment - dietary intake
Time frame: Baseline, week 12, week 24 and follow up at week 52
Dietary assessment - dietary quality
Time frame: Baseline, week 12, week 24 and follow up at week 52
Dietary assessment - dietary adehrence
Time frame: Baseline, week 12, week 24 and follow up at week 52
Quality of life WHOQOL
Time frame: Baseline, week 12, week 24 and follow up at week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional intervention in people with Bipolar Depression and Bipolar Disorder (BD), run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C reactive protein (time frame: Baseline, week 12, week 24 and follow up at week 52). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.