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

Официальное название

The Effect of a Nutritional Intervention Focused on Dietary Pattern in the Cardiovascular Risks of Individuals With Bipolar Disorder

Обзор

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.

Вмешательства

• Поведенческое Nutritional intervention
  7 individual sessions (online) + 6 small group sessions (1-in person + 5 online)

Первичные конечные точки

• C reactive protein [Срок оценки: Baseline, week 12, week 24 and follow up at week 52]
• Total cholesterol and fractions [Срок оценки: Baseline, week 12, week 24 and follow up at week 52]
• Glycemia [Срок оценки: Baseline, week 12, week 24 and follow up at week 52]
• Glycated hemoglobin A1C [Срок оценки: Baseline, week 12, week 24 and follow up at week 52]
• Triglycerides [Срок оценки: Baseline, week 12, week 24 and follow up at week 52]
• HOMA IR [Срок оценки: Baseline, week 12, week 24 and follow up at week 52]
• Apoliporpotein B [Срок оценки: Baseline, week 12, week 24 and follow up at week 52]
• Cardiovascular risk [Срок оценки: Baseline, week 12, week 24 and follow up at week 52]
• Body weight [Срок оценки: Baseline, week 12, week 24 and follow up at week 52]
• Body fat percentage [Срок оценки: Baseline, week 12, week 24 and follow up at week 52]

Вторичные конечные точки (4)

• Dietary assessment - dietary intake [Срок оценки: Baseline, week 12, week 24 and follow up at week 52]
• Dietary assessment - dietary quality [Срок оценки: Baseline, week 12, week 24 and follow up at week 52]
• Dietary assessment - dietary adehrence [Срок оценки: Baseline, week 12, week 24 and follow up at week 52]
• Quality of life WHOQOL [Срок оценки: Baseline, week 12, week 24 and follow up at week 52]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Fernanda Gabriel — São Paulo

Идентификаторы

NCT: NCT06488573 · 25299

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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