Omega-3 Supplementation in HIV Patients With Therapeutic Lifestyle Change Diet.
NCT ID: NCT02537236
Last Updated: 2015-09-02
Study Results
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Basic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2009-01-31
2009-12-31
Brief Summary
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The investigators evaluated the efficiency of the combination of fish oil omega 3 fatty acids to different doses with the Therapeutic Lifestyle Changes (TLC) diet of the National Cholesterol Education Program on the profile of lipids and the corporal weight in patients with HIV treated with HAART.
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Detailed Description
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With a prevalence of 3 cases for every 1000 people from 15 to 49 years, Mexico ranks 16th place in the prevalence of HIV/AIDS in adults in Latin America2.
The state of Jalisco, México, occupies the fourth place in terms of positive cases of HIV-AIDS, in this same plane, the municipalities of Guadalajara, Zapopan, Tlaquepaque and Puerto Vallarta in Jalisco, represent the main populations with the highest number of positive cases by HIV-AIDS.
The HIV positive individuals with Highly Active Antiretroviral Therapy (HAART) or without treatment are facing numerous challenges in terms of management of their health; some of the most disturbing changes are visible in the shape and appearance of the body. In most cases this anatomical changes come accompanied by alterations in biochemical indicators: lipid levels (cholesterol and triglycerides) and insulin resistance4.These adverse effects may have important clinical implications, such as severe lactic acidosis, coronary artery disease and acute pancreatitis5.
In patients with HIV and HAART has published an incidence of hypercholesterolemia and hypertriglyceridemia between 5 and 90% depending on the series, although the true incidence is yet to be determined6. Pharmacological interventions with statins or fibrates in patients infected with HIV are limited partially due to the drug interactions and increase in the frequency of adverse effects7.
Therefore, it is necessary to investigate new alternatives for the management of dyslipidemia in patients infected with HIV with HAART through changes in diet and supplements of fish oil omega 3 fatty acids.
Methods Patients: The investigators enrolled 100 Patients positive to Human Immunodeficiency Virus or Acquired Immunodeficiency Syndrome, and had been receiving ≥2 Highly Active Antiretroviral Therapy, and with diagnostic of dislipidemia according the Mexican Official Standard Norms of 2002, for the prevention, treatment and control of dyslipidemias8.
All the patients were active in the SMART database from HIV/AIDS department of the Civil Hospital in Guadalajara "Fray Antonio Alcalde". Patients were excluded for intolerance or allergy to fish, patients that use or have used in the last 6 weeks supplements or drugs that modify lipids.
Study design During the period from January 2010 to July 2011, was carried out the study with the authorization of the ethics committee of the Civil Hospital in Guadalajara "Fray Antonio Alcalde".
Our subjects were assigned to 5 intervention groups: Groups one= 20 subjects received Therapeutic Lifestyle Changes diet more 1.05 grams of Fatty Acid omega 3. Groups two= 20 subjects received conventional diet more 1.05 grams of Fatty Acid omega three. Groups 3=20 subjects received Therapeutic Lifestyle Changes diet more 2.10 grams of Fatty Acid omega 3. Groups four=20 subjects received conventional diet more 2.10 grams of Fatty Acid omega 3. Groups five= 20 subjects, control group received conventional diet.
The subject assigned to group one and three with TLC diet, received advice from the nutritionist in week 4 and 12 to encourage the consumption of the capsules of omega 3 fatty acids, in addition offered general recommendations to consume dietary fiber and fluids.
The subject assigned to groups two and four with conventional diet, received advice from the nutritionist in the week 4 and 12 to encourage the consumption of the capsules of omega 3 fatty acids without the assistance of special diet.
The requirements of energy and macronutrients were identified in the patients of group one and three.
None of the subjects received advice on the physical activity that could perform.
Statistical analysis
The main objective of this study was to compare the changes in fasting levels of triglycerides (TG), total cholesterol (TC), high density cholesterol (HD-C), low density cholesterol (LD-C), very low density cholesterol (VLD-C), the body weight and body mass index (BMI) against the week 4 and 12.
The safety and tolerability of the study medication were also secondary outcomes.
Statistical analysis was carried out starting with the Kolmogorov-Smirnov test to identify the distribution of variables, then identify the type of distribution of each variable, is continuous with the descriptive statistical analysis for variables with abnormal distribution -non-parametric, with measures of central tendency and dispersion as: the median distance and interquartiles and variables with normal distribution - parametric- :the mean and standard deviation.
Inferential analysis to the intra-group used the Wilcoxon test and Friedman. For the inferential analysis between groups was implemented in the variables of non-normal distribution, the Kruskal-Wallis test; and for variables with normal distribution was used the one-way ANOVA test. Differences were considered statistically significant when the p value was \<0.05 .
The data were processed using the statistical package No.18.0 and are presented in tables and graphics.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group one
20 subjects received Therapeutic Lifestyle Changes diet more 1.05 grams of fish oil omega 3 fatty acids
Omega-3 fatty acid supplementation with fish oil and TLC nutritional intervention.
Omega 3 fatty acid supplementation with fish oil and nutritional counseling of TLC diet.
Group two
20 subjects received conventional diet more 1.05 grams of fish oil omega 3 fatty acids
Omega-3 fatty acids
Omega-3 fatty acid supplementation with fish oil.
Group three
20 subjects received Therapeutic Lifestyle Changes diet more 2.10 grams of fish oil omega 3 fatty acids.
Omega-3 fatty acid supplementation with fish oil and TLC nutritional intervention.
Omega 3 fatty acid supplementation with fish oil and nutritional counseling of TLC diet.
Group four
20 subjects received conventional diet more 2.10 grams of fish oil omega 3 fatty acids
Omega-3 fatty acids
Omega-3 fatty acid supplementation with fish oil.
Group five
20 subjects, control group received conventional diet.
TLC nutritional intervention
nutritional orientation.
Interventions
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Omega-3 fatty acids
Omega-3 fatty acid supplementation with fish oil.
TLC nutritional intervention
nutritional orientation.
Omega-3 fatty acid supplementation with fish oil and TLC nutritional intervention.
Omega 3 fatty acid supplementation with fish oil and nutritional counseling of TLC diet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients older than 18 years positive to HIV/AIDS with HAART
* Patients who agreed to sign consent under written information
* Patients that had some type of dyslipidemia according the Mexican Norms of 2002.
Exclusion Criteria
* Patients with intolerance or allergy to fish oil
* Patient record in the database SMART but inactive.
* Patients who use or have used in the last 6 weeks food supplements that modify lipids.
* Patient who have not attended two of the four set appointments for valuation.
18 Years
60 Years
ALL
No
Sponsors
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Hospital Civil de Guadalajara
OTHER
Instituto Mexicano del Seguro Social
OTHER_GOV
Responsible Party
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Alejandro Gonzalez-Ojeda
MD., Ph.D., F.A.C.S.
Principal Investigators
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Alejandro González-Ojeda, MD. PhD. F.A.C.S.
Role: STUDY_DIRECTOR
Instituto Mexicano del Seguro Social
References
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Carr A, Samaras K, Burton S, Law M, Freund J, Chisholm DJ, Cooper DA. A syndrome of peripheral lipodystrophy, hyperlipidaemia and insulin resistance in patients receiving HIV protease inhibitors. AIDS. 1998 May 7;12(7):F51-8. doi: 10.1097/00002030-199807000-00003.
Mulligan K, Grunfeld C, Tai VW, Algren H, Pang M, Chernoff DN, Lo JC, Schambelan M. Hyperlipidemia and insulin resistance are induced by protease inhibitors independent of changes in body composition in patients with HIV infection. J Acquir Immune Defic Syndr. 2000 Jan 1;23(1):35-43. doi: 10.1097/00126334-200001010-00005.
Wohl DA, Tien HC, Busby M, Cunningham C, Macintosh B, Napravnik S, Danan E, Donovan K, Hossenipour M, Simpson RJ Jr. Randomized study of the safety and efficacy of fish oil (omega-3 fatty acid) supplementation with dietary and exercise counseling for the treatment of antiretroviral therapy-associated hypertriglyceridemia. Clin Infect Dis. 2005 Nov 15;41(10):1498-504. doi: 10.1086/497273. Epub 2005 Oct 11.
Other Identifiers
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omega-3-HIV/2009
Identifier Type: -
Identifier Source: org_study_id
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