Antioxidant in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate

NCT ID: NCT03531749

Last Updated: 2018-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-05-31

Brief 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.

Detailed Description

Since Patients HIV+ suffer oxidative stress, microencapsulated of red pomegranate juice will be evaluated for decreasing oxidative stress in HIV+ patients it will be compared with patients treated with ascorbic acid. The supplementation will take 90 days and blood samples were taken four times: at the beginning of the study and every 30 days thereafter. Antioxidant activity in the blood serum was measured by the DPPH and ABTS+ methods lipid peroxidation was measured as stress oxidative markers

Conditions

HIV Positive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HIV+ MRPJ

Supplementation with microencapsulated (1g/d) for 90 days

Group Type: EXPERIMENTAL

HIV+ MRPJ

Intervention Type: DIETARY_SUPPLEMENT

supplemented with (1g/d) MRPJ

HIV+ ascorbic acid

Supplementation with ascorbic acid (1g/d) for 90 days

Group Type: EXPERIMENTAL

HIV+ ascorbic acid

Intervention Type: DIETARY_SUPPLEMENT

Supplemented with (1g/d) AA

HIV- MRPJ

Supplementation with microencapsulated (1g/d) for 90 days

Group Type: EXPERIMENTAL

HIV+ MRPJ

Intervention Type: DIETARY_SUPPLEMENT

supplemented with (1g/d) MRPJ

HIV- ascorbic acid

Supplementation with ascorbic acid (1g/d) for 90

Group Type: EXPERIMENTAL

HIV+ ascorbic acid

Intervention Type: DIETARY_SUPPLEMENT

Supplemented with (1g/d) AA

HIV- Control

Unsupplemented

Group Type: NO_INTERVENTION

No interventions assigned to this group

HIV+ Control

Unsupplemented

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HIV+ MRPJ

supplemented with (1g/d) MRPJ

Intervention Type: DIETARY_SUPPLEMENT

HIV+ ascorbic acid

Supplemented with (1g/d) AA

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Over 18 years
• Having a positive HIV diagnosis
• Having antiretroviral treatment
• Status of one of the following clinical categories A1, A2, B1 and B2 at the time of the study start,
• Residents of the city of Pachuca

Exclusion Criteria

• Subjects taking antioxidants
• Pregnant women.
• Subjects taking of angiotensin-converting enzyme inhibitors (e.g.captopril or enalapril).
• subjects who do not comply with at least 95% of the adherence of the supplementation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Council of Science and Technology, Mexico

OTHER

Sponsor Role: collaborator

Universidad Autónoma del Estado de Hidalgo

OTHER

Sponsor Role: lead

Responsible Party

Gabriel Betanzos Cabrera

Professor-Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

FSSA2016051

Identifier Type: -

Identifier Source: org_study_id