Evaluation of the effectiveness of omega 3 supplementation in individuals with redistribuition of body fat related to the use of HIV medications. Relationship with cell integrity measure

Phase 4

• Conditions: E00-E90; ipodystrophy not elsewhere classified

• Registration Number: RBR-9whhh7w
• Lead Sponsor: úcleo de Medicina Tropical- Universidade Federal do Pará

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-02-28
• Study Start: 2022-05-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

This study will include patients with HIV-associated lipodystrophic syndrome, adults, of both sexes, aged over 18 years, with a previous diagnosis of the disease provided by the team at Hospital Jean Bitar, who are undergoing outpatient follow-up and treatment with antiretroviral ( ART). It is necessary that the patient agrees to participate in the research and sign the Informed Consent Form (ANNEX A).

Exclusion Criteria

All individuals with SLHA who present a condition of vulnerability and / or associated disease that negatively interferes with the predicted values ??of phase angle, such as severe obesity (BMI = 40kg / m2), presentation of the picture will be excluded from the population covered by the inclusion criteria. edema, ascites, patients with neurological diseases that compromise the understanding of the study, in case of use of pacemaker or any metal prosthesis / orthosis, kidney disease, patients using diuretics, as well as pregnant or lactating women. Those who refuse to participate spontaneously in this research protocol will also not be included in the study, in addition to all those people who do not adequately prepare for the bioimpedance exam, as well as those who do not demonstrate adherence to treatment.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to find an increase in the phase angle and body cell mass in group 1 patients (dietotherapeutic orientation + supplementation) compared to group 2 (dietotherapeutic orientation, and the outcome is verified by the technique of electrical bioimpedance, with tetrapolar model, which quantifies the measurements linearly, through mathematical equation, relating the variable of resistance and reactance of cell membranes. The presentation and analysis of the parameters will take place through tables and application of statistical tests such as Z test, for analysis between groups and T test for correlation of pre- and post-intervention status, within the same group, expecting as positive results alpha level of decision 0.05.

Secondary Outcome Measures

Name	Time	Method
It is expected to improve the lipid profile of group 1 (dietotherapeutic orientation + supplementation) in relation to group 2 (dietotherapeutic guidance), and the outcome is verified by comparing laboratory tests performed in the institution's own laboratory, by enzymatic method for quantification of total cholesterol and triglycerides; for HDL using elimination/catalase method; LDL and VDL by calculation according to Lipid Rearch Clinic Programs. The presentation and analysis of the parameters will take place through tables and application of statistical tests such as Z test, for analysis between groups and T test for correlation of pre- and post-intervention status, within the same group, expecting as positive results alpha level of decision 0.05.