Revista Adolescência e Saúde

Revista Oficial do Núcleo de Estudos da Saúde do Adolescente / UERJ

NESA Publicação oficial
ISSN: 2177-5281 (Online)

Vol. 15 nº 3 - Jul/Sep - 2018

Original Article Imprimir 

Páginas 89 a 100


Nutritional therapy on lipid profile in adolescents with HIV/AIDS using antiretroviral therapy: a randomized controlled trial

La terapia nutricional en la dislipidemia de adolescentes con VIH/SIDA en uso de terapia antirretroviral: un ensayo clínico randomizado

A terapia nutricional na dislipidemia de adolescentes com HIV/AIDS em uso de terapia antirretroviral: um ensaio clínico randomizado

Autores: Caroline Barbosa Schmitz1; Carmem Lucia Oliveira da Silva2; Daniéla Oliveira Magro3; Karen Olivia Bazzo Goulart4; Michelli Cristina Silva de Assis5; Alexandre Ramos Lazzarotto6

1. Master's Degree in Health and Human Development from La Salle University (UNISALLE). Canoas, RS, Brazil
2. Medical Pediatrician Coordinator of the AIDS Program at the Hospital de Clínicas of Porto Alegre (HCPA). Porto Alegre, RS, Brazil
3. Post-doctorate in Surgery Sciences from the State University of Campinas (UNICAMP). Nutritionist, Researcher of the Department of Surgery by the Faculty of Medical Sciences of the State University of Campinas (UNICAMP). São Paulo. SP, Brazil
4. Doctorate in Biotechnology from the University of Caxias do Sul (UCS). Caxias do Sul, RS, Brazil
5. Doctorate in Medical Sciences from the Postgraduate Program in Medicine of the Federal University of Rio Grande do Sul (UFRGS). Nurse at the Hospital de Clínicas de Porto Alegre (HCPA). Porto Alegre, RS, Brazil
6. Master and Doctorate in Human Movement Sciences from the Federal University of Rio Grande do Sul (UFRGS). Professor of Master in Health and Human Development at La Salle University. Canoas, RS, Brazil

Alexandre Ramos Lazzarotto
Universidade La Salle
Av. Victor Barreto, 2288 - Centro
Canoas, RS, Brasil. CEP: 92010-000
(alazzar@terra.com.br)

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How to cite this article

Keywords: HIV, Acquired Immunodeficiency Syndrome, dyslipidemias, adolescent, nutrition therapy.
Palabra Clave: HIV, Síndrome de Inmunodeficiencia Adquirida, dislipidemias, adolescente, terapia nutricional.
Descritores: HIV, Síndrome de Imunodeficiência Adquirida, dislipidemias, adolescente, terapia nutricional.

Abstract:
OBJECTIVE: Evaluates the nutritional therapyon the lipid profile of HIV-infected adolescents using Highly active antiretroviral therapy (HAART) and with dyslipidemia.
METHODS: 20 adolescents participated in the study, 11 were female. Of which 10 were randomly selected for the nutritional intervention group, which received nutritional counseling for 12 weeks, and 10 for the control group who received routine follow-up. Lipid profile and 24-hour dietary recall were obtained before and after the intervention for both groups. Data were analyzed by intention to treat using mixed models.
RESULTS: Serum cholesterol levels and triglycerides were reduced from 282 ± 69 to 246 ± 67 mg/dL (p=0.001) and from 137 ± 67 to 104 ± 39 mg/dL (p=0.001) respectively, by nutritional intervention, whereas in the control group both cholesterol and triglycerides increased (from 287 ± 72 for 307 ± 76 mg/dL, p=0.047, and 135 ± 70 to 177 ± 81 mg/dL, p=0.001, respectively).
CONCLUSION: Among adolescents with HIV/AIDS and dyslipidemia using HAART, nutritional therapy was effective in reducing serum cholesterol, triglyceride levels and BMI.

Resumen:
OBJETIVO: Evaluar la terapia nutricional en la dislipidemia de adolescentes con VIH/SIDA en uso de Terapia Antirretroviral (TARV).
MÉTODOS: 20 adolescentes participaron del estudio, siendo que 11 eran del sexo femenino. De estos, 10 fueron seleccionados aleatoriamente para el grupo de intervención nutricional, que recibió seguimiento nutricional por 12 semanas, y 10 para el grupo de control con consultas médicas de rutina. El perfil lipídico y el recordatorio de 24 horas fueron recolectados en el período basal y al final del estudio para ambos grupos.
RESULTADOS: Los niveles séricos de colesterol y triglicéridos se redujo de 282 ± 69 a 246 ± 67 mg / dL (p = 0,001) y de 137 ± 67 a 104 ± 39 mg dL (p = 0,001), respectivamente, por intervención nutricional, mientras que en el grupo control, ambos colesterol y triglicéridos aumentaron (de 287 ± 72 a 307 ± 76 mg / dL, p = 0,047 y 135 ± 70 a 177 ± 81mg / dL, p = 0,001, respectivamente).
CONCLUSIÓN: La terapia nutricional redujo los niveles de colesterol total y triglicéridos no permitiendo el empeoramiento de la dislipidemia en estos pacientes.

Resumo:
OBJETIVO: Avaliar a terapia nutricional na dislipidemia de adolescentes com HIV/AIDS em uso de Terapia Antirretroviral (TARV).
MÉTODOS: 20 adolescentes participaram do estudo, sendo que 11 eram do sexo feminino. Desses, 10 foram selecionados randomicamente para o grupo de intervenção nutricional, que recebeu acompanhamento nutricional por 12 semanas, e 10 para o grupo de controle com consultas médicas de rotina. O perfil lipídico e o recordatório de 24 horas foram coletados no período basal e ao fim do estudo para ambos os grupos.
RESULTADOS: Os níveis séricos de colesterol e triglicerídeos foram reduzidos de 282 ± 69 para 246 ± 67 mg/dL (p = 0,001) e de 137 ± 67 para 104 ± 39 mg dL (p = 0,001), respectivamente, por intervenção nutricional, enquanto no grupo controle, ambos colesterol e triglicerídeos aumentaram (de 287 ± 72 para 307 ± 76 mg/dL, p = 0,047 e 135 ± 70 para 177 ± 81mg/dL, p = 0,001, respectivamente).
CONCLUSÃO: A terapia nutricional reduziu os níveis de colesterol total e triglicerídeos não permitindo a piora da dislipidemia nestes pacientes.

INTRODUCTION

The clinical course and the epidemic profile of AIDS were modified by the development of combination antiretroviral therapy (ART), which provides a sustained suppression of viral replication1,2. Approximately 313,000 people received free ART through the Unified Health System, of which 4.3% were adolescents3,4.

In patients with good adherence to pharmacotherapy, prolonged use is associated with metabolic and bodily alterations, such as lipodystrophy and dyslipidemia, which is associated with a higher probability of cardiovascular events and death. The relationship between ART and dyslipidemia is still not fully understood and the management of these alterations can be decisive for patients' longevity and quality of life5.

The World Health Organization (WHO) recommends that nutritional interventions be part of all AIDS control and treatment programs, since diet and nutritional therapy can improve the adherence and effectiveness of ART, in addition to reducing abnormalities metabolic6.

Due to the existence of studies with only the adult population, research is necessary to investigate the physical, metabolic and dietary alterations that are occurring in children and adolescents with HIV and the administration of ART. Werneret al.9 cite the need to carry out more studies for a better evaluation of the cause of ART, indicating that atherosclerotic disease has its beginning in childhood and that the changes in eating habits and lifestyle with the regular practice of physical exercises They should be emphasized in this group of patients as an integral part of the treatment. They corroborate this statement Sarniet al.10, when they show the high frequency of dyslipidemia and lipodystrophy in children and adolescents, showing the relationship of these with the ART administered and making reference to the importance of multiprofessional care to these patients with the involvement of nutritional education. Second Sharmaet al.11 Diet is a potential modifiable factor that can alter the metabolic risk in children with HIV / AIDS, since continuous monitoring of caloric and carbohydrate intake is essential to avoid future increases in adiposity, and may contribute for the risk of cardiovascular disease in infected adolescents. Unfortunately, studies and interventions with these populations are still scarce.

Thus, a study was carried out with the objective of evaluating the nutritional therapy in the dyslipidemia of adolescents with HIV / AIDS in the use of ART.


METHODS

Study design

A randomized clinical trial was conducted at a national referral center for HIV / AIDS in southern Brazil. The study was approved by the research ethics committee of the Hospital de Clínicas de Porto Alegre (Register at ClinicalTrials.gov under number NCT03021889).

Sample Selection

The sample was constituted by adolescents between 13 and 19 years of age with a diagnosis of HIV-1 infection, in treatment with antiretroviral for at least three months, and who presented dyslipidemia characterized according to the 1st Brazilian Directive for the Prevention of Atherosclerosis in Children and Adolescence (2005)12. These adolescents were recruited at the Pediatric Infectious Disease Outpatient Clinic Hospital of Porto Alegre (Rio Grande do Sul, Brazil). The following were not included in the study: pregnant women, patients with active opportunistic infection, mental deficiency, diabetes mellitus, patients on lipid-lowering drugs and patients who didn´t know of their HIV-positive diagnosis. Dyslipidemia was defined by plasma levels of total fasting. Cholesterol > 170mg/dL associated with: Triglycerides ≥ 130mg/dLy and/or LDL cholesterol ≥ 130mg/dL, as indicated by the Brazilian Society of Cardiology12.

The initial sample size was 36 individuals in each group, considering a standard deviation of 40 for an alpha error of 5% and a reliability power of 80%. This calculation was made with the Winpepi software. A planned interim analysis for power re-evaluation was performed when 20 patients completed the 12-week follow-up period. In this analysis, the sample size of 10 patients in each group showed sufficient power to detect significant effect of nutritional therapy, which resulted in the final total sample of 20 patients.

Randomization and interventions

During the initial evaluation, all participants received nutritional guidelines, emphasizing the benefits of healthy eating habits. At this time, the 24-hour food recall (RA-24h) 13 and the clinical form that addressed the following items were applied: identification data of the adolescent (age and sex), history of the disease (type of transmission and date of diagnosis) ), the current pathological history (current therapeutic scheme, time of use of current ART, time of use of total ART). The randomization was generated from a sequence based on a table of random numbers in the Excel program, in which the cells listed up to 20 were used for the draw of the patients, which were identified through the last two digits of their record. . The 20 patients were randomized into two groups. The group with nutritional therapy (GTN) 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 the Management of HIV Infection in children and adolescents14. In addition, participants in the therapy group received biweekly phone calls for nutritional counseling. The control group (CG) received the same baseline nutritional orientation, but followed only the ambulatory care routine, which consisted of medical accompaniment with infectious diseases, hebiatra and assistant team with the following professionals: pharmacists, social assistants and nursing technicians.

RA-24h, lipid profile and BMI were performed in both groups in the basal period and at the end of the study. Participants were advised not to exercise vigorous physical activity and not to drink alcohol within 24 hours before the blood collection.

Anthropometric evaluation

The total body mass was measured with digital anthropometric scale (Urano®) with a capacity of 150 Kg and sensitivity of 0.1 Kg, barefoot, with the minimum possible clothes, in the center of the equipment, erect, with the feet together and the arms extended along the body. The total body mass was recorded in Kg (kilograms) with a decimal. The stature was measured through a wall stadiometer Model 211 by Tonelli Equipos Médicos Ltda®. The Body Mass Index (BMI) was calculated from the total body mass divided by the height squared [BMI = Total Body Mass (kg) / (Height2) (m)].

Dietary Evaluation and Intervention

The feeding schemes were planned individually considering the nutritional needs, the socioeconomic situation and the eating habits of each individual. The food plan provided included the description of the food, schedules, quantities in homemade measures and a list of prohibited foods.

The information on food consumption was obtained through the filling of RA-24h, in which patients reported in detail the food and beverages consumed in the 24 hours prior to the consultation. As a way to increase the accuracy of the information, a photographic registry manual was used for food surveys. For the quantitative analysis of energy, macronutrients and total fiber ingested, the program diet Win Professional 2.0, 2015 was used. For this, the household measurements were converted into grams and milliliters. Foods and preparations not listed in the program were included with the help of supplementary tables.

The nutritional therapy followed the recommendations established by the Clinical Protocol and Therapeutic Guidelines for the Management of HIV Infection in children and adolescents where adolescents with total cholesterol> 150mg / dL and LDL cholesterol between 100 and 130mg/dL received the Type I diet that recommended daily consumption of up to 30% of calories in the form of fats, up to 10% of saturated fats and cholesterol up to 100 mg/1,000 calories (maximum: 300 mg / day)14.

For all participants of the GTN, the motivation strategy of the patient was developed, discussing information on dyslipidemia, importance of nutritional therapy in this situation, information on food groups, their functions and main sources, foods rich in lipids and cholesterol, stimulus for health the ingestion of fibers and the adoption of healthy eating habits. As an auxiliary educational measure, which confers the degree of standardization to the information, a graphic material specifically created for this purpose was elaborated, which was distributed to each one of the participants. At the end of the consultations, some goals were established in common agreement with the patient, based on the detection of possible inappropriate eating behaviors, to favor adherence to the therapy and its motivation.

Lipid profile

The lipid profile included measurements of total cholesterol (TC), high density lipoprotein cholesterol (HDL-c), triglycerides (TG) and low density lipoprotein cholesterol (LDL-c). The TC and TG levels were measured using a colorimetric enzymatic method and HDL-c, the homogeneous colorimetric enzymatic method (Hitachi 917, Roche Diagnostics GmbH, Mannheim, Germany). The LDL-c was calculated according to the Friedewald formula if the plasma levels were <400 mg / dL12.

Dyslipidemia was defined by plasma levels of total cholesterol> 170 mg / dL associated with: triglycerides ≥ 130mg and / or LDL cholesterol ≥ 130mg/dL12.

Statistical analysis

To verify the normality of the data, the Shapiro-Wilk test was used. For the comparison of the categorical variables, the chi-square test was used and, for the continuous variables, the Mann-Whitney test. The comparison of the means according to the dietary, immunological and biochemical variables of the groups, times and interaction (group x time) was performed by means of the equations model of generalized estimates (GEE)15. An unstructured work correlation matrix, a robust covariance matrix and a normal distribution with identity connection function were used. To compare the averages of the interaction categories, the Bonferroni post-hoc test was used. The level of significance adopted was p <0.05. The tests were carried out with the PASW 18.0 software for Windows.


RESULTS

Of the 37 triad patients, 26 (70.27%) were considered eligible and included in the study. Of these, 20 were analyzed. Six patients, three of the GTN and two of the CG were excluded from the analysis due to the non-appearance of the return consultations in the first month. A CG patient was excluded from the analysis due to the initiation of lipid-lowering medication during the study (Figure 1).


Figure 1. Flowchart of the study participants.



Table 1 presents the demographic, anthropometric, biochemical, immunological, food consumption characteristics and the prescribed ART for the CG and NGT in the initial evaluation. The groups presented similar characteristics, with a predominance of women. The type of transmission of the virus was 100% vertical. Patients' therapeutic schemes included two nucleotide reverse transcriptase inhibitors (NRTIs) and a protease inhibitor (PI) or a non-nucleotide reverse transcriptase inhibitor (NRTII). The combination most used by the patients was tenofovir, lamivudine and efavirenz (35%). During the study, no patient needed to replace the medication.




The median viral load remained the same in the groups (p = 0.678). The means for viral load were calculated only with the patients who had detectable viral load, being 3 patients of the GC and 2 patients of the GTN, since 75% of the total sample had undetectable viral load, that is, less than 50 copies per milliliter of blood, configuring clinical stability.

Table 2 presents the estimate of the habitual food consumption of energy and macronutrients that was obtained by the RA-24h, at the basal and final moment. The nutritional intervention resulted in the reduction of the intake of total calories, of the percentages of lipids, saturated fatty acids, monounsaturated fatty acids and polyunsaturated fatty acids. It also resulted in increased fiber intake and reduced milligrams of cholesterol ingested per day. The percentage of ingested carbohydrates obtained small reduction in both groups, however, there was a significant increase in the percentage of protein in the GTN.




Table 3 presents the total body mass index (BMI) values of the study participants. According to the results, the BMI remained stable in the GTN, while in the CG there was a significant increase at the end of the study.




In the biochemical evaluation described in Table 3, nutritional therapy reduced plasma levels of total cholesterol (Figure 2) in GTN, with a significant increase in GC.


Figure 2. Effect of nutritional therapy on plasma levels of total cholesterol in the period of intervention.



The reduction of the levels of LDL-C in the GTN and in the GC remained stable, but at the end of the study, the levels of LDL-C presented a significant reduction for the CG. The HDL-C levels showed a similar increase, however, they didn´t present significant differences between the groups. Triglyceride levels decreased in the GTN, while in the GC they increased significantly.

At the end of the study, only one participant in the intervention group was outside the patterns that characterize dyslipidemia, that is, with total cholesterol> 170mg/dl.

Figure 2 shows the total cholesterol levels in both groups during the intervention period, in which it was possible to observe the decrease in total cholesterol levels from 282mg/dL to 246 mg/dL in the GTN and the significant increase of 287 mg/dl at 307 mg/dl in the GC.


DISCUSSION

In the study there was an average reduction of 36.1 mg / dL in total cholesterol levels and 33 mg/dL in triglyceride levels. The nutritional therapy had, therefore, a positive effect in the control of dyslipidemia. However, studies8,7,16,17 that evaluated diet in the control of dyslipidemias in individuals living with HIV/AIDS still highlight the need for new work in order to elucidate this possible relationship.

In 2006, Terryet al.7 conducted a randomized clinical trial with 30 adults living with HIV/AIDS using ART who had dyslipidemia. The intervention occurred during 8 weeks with diet (not specified by the authors) associated with physical exercise. The results found were reduced levels of total cholesterol, triglycerides and LDL cholesterol. A randomized clinical trial conducted in Australia with adults with dyslipidemia, using a 16-week diet intervention following recommendations from the National Heart Foundation of Australia and omega-3 supplement (3g/day), found reduction in total cholesterol levels and triglycerides8. None of the studies investigated the isolated dietary intervention, as they evaluated the association of other interventions with diet.

Barrios et al.16 When assessing 230 individuals without GC, they found significant reductions in total cholesterol and triglyceride levels after three and six months of a low-fat diet. More recently, researchers from the southern region of Brazil conducted a randomized clinical trial with adults, initiating a treatment that included nutritional monitoring for 12 months. The group that received intervention in the diet had no variation in lipid profile and BMI during the follow-up of the study. The control group, on the other hand, had a three times greater risk of developing dyslipidemia than the intervention group17. The results of the present study corroborate the work of Lazzarettiet al.17, since both showed that the nutritional intervention can be safe and effective in reducing dyslipidemia in individuals with HIV / AIDS.

The levels of LDL-c remained stable for both groups and in the GC the levels of total cholesterol, triglycerides and BMI increased significantly. The results showed a 31% increase in serum triglyceride levels.

Although the average results of total cholesterol didn´t reach normal, after 12 weeks of intervention, the reduction was significant (p = 0.047). In relation to CG, mean cholesterol values increased by 10.4% in the second measurement. The cause of this increase in cholesterol and triglyceride levels can be attributed to the lack of dietary guidance.

Estimates of the dietary intake of people living with HIV / AIDS vary widely between studies, but according to reports in the literature, dietary intervention reduces the total calorie intake of total saturated fat and dietary cholesterol and increases the fiber ingestion18,19. There has been an improvement in the total consumption of lipids and in the reduction of lipid percentages, especially the reduction of monounsaturated fatty acids, must be attributed to the reduction in consumption of red meat, whole milk and dairy products, which are the main sources of monounsaturated fatty acids20.

The low total intake of fiber was also reported in 2010, when the researchers discovered that inadequate intake of these nutrient prevailed in individuals older than 9 years. This fact can contribute to the increase of cholesterol in the serum, since the fibers would have the capacity to connect to certain substances in the intestine, including cholesterol, thus reducing its absorption9.

The body composition and metabolic alterations observed in patients infected with HIV are associated with specific clinical aspects21,22. The adverse effects caused by antiretroviral therapy that occur as a result of prolonged use should be diagnosed and treated as in the HIV-negative population that presents such alterations. Protease inhibitors play a leading role in the genesis of dyslipidemia and their use is essential in the control of viral replication23,24.

The researchers reported changes in the nutritional status of patients with HIV / AIDS and the importance of an adequate nutritional treatment, with nutrient deficiency being one of the most common implications in these patients due to dietary intake and precarious metabolic changes, such as the increase in of protein catabolism25. There are few studies with children and adolescents infected with HIV26.


CONCLUSION

The results of the randomized clinical trial conducted with adolescents with HIV / AIDS, showed that nutritional therapy can be considered as a strategy for the control of dyslipidemia.


ACKNOWLEDGMENT NOTE

1 - We especially thank the participating patients and their caregivers for the collaboration with the study.

2 - This work received financial support from the Research and Events Incentive Fund of the Hospital de Clínicas of Porto Alegre.


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