Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488573
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-17
Brief Title:
The Effect of a Nutritional Intervention Focused on Dietary Pattern in the Cardiovascular Risks of Individuals With Bipolar Disorder
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
The Effect of a Nutritional Intervention Focused on Dietary Pattern in the Cardiovascular Risks of Individuals With Bipolar Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Individuals with Bipolar Disorder BD have twice the risk of being affected by metabolic comorbidities and a 18-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 individuals 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None