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Antioxidant in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate

NCT03531749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-05-22

No results posted yet for this study

Summary

Human immunodeficiency virus (HIV) infection continues to be a pandemic, Mexico has around 184,000 people infected by this virus. A common metabolic problem for these patients is oxidative stress (OS), which has been related with the progression of the disease and the presence of comorbidities. Pomegranate is a fruit rich in antioxidants, which potentially can inhibit or reduce deleterious metabolic compounds resulting from OS; however; it has never been tested in patients infected with HIV. The present project was done in patients HIV+ from state of Hidalgo in order to see the effects of microencapsulated red pomegranate juice (MRPJ) and ascorbic acid (AA) on antioxidant activity and lipid peroxidation both biomarkers of oxidative stress. Sixty subjects were recruited, 30 HIV positive (HIV+) and 30 HIV negative (HIV-). Three subgroups (n=10) were formed from each group: 1) supplemented with (1g/d) MRPJ; 2) supplemented with 1g/d AA; and 3) control group (unsupplemented). The intervention lasted 90 days and blood samples were taken four times: at the beginning and every 30 days. Antioxidant activity in the blood serum was measured by the DPPH (2,2-diphenyl-1-picrylhydrazyl) and ABTS + (2,2'-azino-bis(3-ethylbenzothiazoline-6-sulphonic acid) methods while lipid peroxidation by malondialdehyde (MDA) levels which was measured by TBARS method. The baseline results showed a significant decrease of antioxidant activity in HIV+ groups compared to the HIV- groups, although there was no significant difference in lipid peroxidation, as measured by MDA assay levels. Several studies suggest that the reduction of antioxidant activity is a consequence of the infection and the antiretroviral treatment, although the organism tries to reestablish it unbalance it usually fails, thus (OS) is significant in these patients. The groups that received AA had antioxidant activity greater than the MRPJ treated. MRPJ treatment, however, the groups that received MRPJ had significantly reduced lipid peroxidation. Reduced lipid peroxidation could have more beneficial effects on HIV+ subjects since the reduction of markers of OS, such as lipid peroxidation, has been associated with reductions in the risk of death from HIV.

Conditions

  • HIV Positive

Interventions

DIETARY_SUPPLEMENT

HIV+ MRPJ

supplemented with (1g/d) MRPJ

DIETARY_SUPPLEMENT

HIV+ ascorbic acid

Supplemented with (1g/d) AA

Sponsors & Collaborators

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • Universidad Autónoma del Estado de Hidalgo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-05-31
Completion
2017-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03531749 on ClinicalTrials.gov