Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment

Nutritional Therapy Improves Dyslipidemia in HIV Infected Teenagers With Antiretroviral Treatment: a Randomized Controlled Trial

Introduction: Prolonged use of antiretroviral therapy is associated with metabolic and bodily changes such as lipodystrophy, diabetes mellitus, insulin resistance and dyslipidemia latter being associated with a higher chance of cardiovascular events and death.

Objective: To evaluate the effect of nutritional therapy in dyslipidemic adolescents living with HIV / AIDS in antiretroviral therapy.

Method: This is a randomized clinical trial with young people 13-19 years in outpatient treatment in a general hospital to present dyslipidemia. The intervention group received nutritional counseling for 12 weeks and weekly flights to nutritional counseling. The control group received standard care consisting of medical care. Demographic, clinical, nutritional variables, food surveys and lipid profiles were collected at baseline and at the end of the study for both groups.

Study Overview

• Status: Completed
• Conditions: Dyslipidemias; Hiv; Adolescent Behavior
• Intervention / Treatment: Behavioral: Nutritional therapy; Behavioral: Control group

Detailed Description

This is a open randomized clinical trial. The participants were adolescents (13 to 19 years old) diagnosed with HIV / AIDS from the Pediatric Infectious Disease Outpatient Clinic - zone 4, from a tertiary care university hospital in the South Region in Brazil, along with their caregivers. Present Dyslipidemia, characterized by Total Cholesterol> 200mg / dL associated with:Triglycerides ≥ 150mg HDL cholesterol (male <40 mg / dL and female <50 mg / dL) LDL cholesterol ≥ 160 mg / dL. The clinical profile, immunological, virological, the biochemical parameters will be accessed by the patient's chart and the dietary parameters will be evaluated by means of 24-hour reminder instrument. The sample was calculated, using a software, from an alpha error of 5%, reliability power of 80%, to obtain detection difference and standard deviation for each of the group of 40, totaling 36 patients.

The randomization will be performed through simple randomization in blocks of 2 patients generated by computer program, available at www.randomization.com.

The intervention group received nutritional counseling for 12 weeks and weekly flights to nutritional counseling. The control group received standard care consisting of medical care. Demographic, clinical, nutritional variables, food surveys and lipid profiles were collected at baseline and at the end of the study for both groups.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed HIV infection with a positive result obtained by performing a screening test for anti-HIV-1 and anti-HIV-2 and at least one confirmatory test;
• Being on antiretroviral therapy for at least three months prior to the start of the study;
• Present current biochemical exams: Dyslipidemia, characterized by Total Cholesterol> 170mg / dL associated with: Triglycerides greater than or equal to LDL cholesterol ≥ 130 mg / dL;
• Availability to participate in the nutritional intervention with a low fat diet.

Exclusion Criteria:

• Pregnant women;
• Patients with active opportunistic infections;
• Cognitive deficits;
• Diabetes mellitus;
• Patients taking lipid-lowering drugs;
• Patients who are unaware of their HIV diagnosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional therapy group; The group nutritional therapy intervention was subjected to a protocol that included: nutritional counseling and weekly phone calls for 12 weeks.	Behavioral: Nutritional therapy; The nutritional therapy intervention group received monthly nutritional guidelines for 12 weeks focusing on the diet for dyslipidemia, based on the recommendation of the type I diet of the Clinical Protocol and Therapeutic Guidelines for Management of HIV Infection in children and adolescents. In addition, participants in the intervention group received weekly phone calls for nutritional counseling.
Other: Control group; The control group received conventional care consisting of usual medical care. The control group was followed according to the ambulatory care routine, which consists of medical follow-up by the assistant team.	Behavioral: Control group; The control group was followed according to the ambulatory care routine, which consists of medical follow-up by the assistant team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood plasma level of total cholesterol	Total blood cholesterol level will be assessed by blood test	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food intake	Food intake will be assessed a 24-hour reminder	12 months
Nutritional status	Will be assessed by body mass index	12 months
Blood plasma level of triglycerides	Triglycerides level will be assessed by blood test	12 months
Blood plasma level of HDL cholesterol	HDL cholesterol level will be assessed by blood test	12 months

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Centro Universitario La Salle
• Investigators: Principal Investigator: Michelli S de Assis, PhD, Nurse Research

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Adolescents; Dyslipidemia; Nutritional Therapy; HIV / AIDS
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: 150018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED