Antioxidant in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate

Antioxidant Activity and Lipid Peroxidation Status in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate

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.

Study Overview

• Status: Completed
• Conditions: HIV Positive
• Intervention / Treatment: Dietary supplement: HIV+ MRPJ; Dietary supplement: HIV+ ascorbic acid

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIV+ MRPJ; Supplementation with microencapsulated (1g/d) for 90 days	Dietary supplement: HIV+ MRPJ; supplemented with (1g/d) MRPJ
Experimental: HIV+ ascorbic acid; Supplementation with ascorbic acid (1g/d) for 90 days	Dietary supplement: HIV+ ascorbic acid; Supplemented with (1g/d) AA
Experimental: HIV- MRPJ; Supplementation with microencapsulated (1g/d) for 90 days	Dietary supplement: HIV+ MRPJ; supplemented with (1g/d) MRPJ
Experimental: HIV- ascorbic acid; Supplementation with ascorbic acid (1g/d) for 90	Dietary supplement: HIV+ ascorbic acid; Supplemented with (1g/d) AA
No Intervention: HIV- Control; Unsupplemented
No Intervention: HIV+ Control; Unsupplemented

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical analyses to determine antioxidant capacity	Four different tests for antioxidant activity were utilized. Plasma antioxidant capacity, catalase, H2O2, and TBARS	At 0 time (baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical analyses to determine antioxidant capacity	Four different tests for antioxidant activity were utilized. Plasma antioxidant capacity, catalase, H2O2, and TBARS	30 days after intervention

Collaborators and Investigators

• Sponsor: Universidad Autónoma del Estado de Hidalgo
• Collaborators: National Council of Science and Technology, Mexico

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: November 1, 2017
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: FSSA2016051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No