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Antioxidant in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate

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ClinicalTrials.gov Identifier: NCT03531749
Recruitment Status : Completed
First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Gabriel Betanzos Cabrera, Universidad Autónoma del Estado de Hidalgo

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.

Condition or disease Intervention/treatment Phase
HIV Positive Dietary Supplement: HIV+ MRPJ Dietary Supplement: HIV+ ascorbic acid Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective double-blind randomized clinical trial
Masking: Double (Participant, Investigator)
Masking Description: A prospective double-blind, randomized clinical trial of microencapsulated of red pomegranate to treat HIV-infected patients
Primary Purpose: Treatment
Official Title: Antioxidant Activity and Lipid Peroxidation Status in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate
Study Start Date : January 2017
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Biochemical analyses to determine antioxidant capacity [ Time Frame: At 0 time (baseline) ]
    Four different tests for antioxidant activity were utilized. Plasma antioxidant capacity, catalase, H2O2, and TBARS


Secondary Outcome Measures :
  1. Biochemical analyses to determine antioxidant capacity [ Time Frame: 30 days after intervention ]
    Four different tests for antioxidant activity were utilized. Plasma antioxidant capacity, catalase, H2O2, and TBARS



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Responsible Party: Gabriel Betanzos Cabrera, Professor-Researcher, Universidad Autónoma del Estado de Hidalgo
ClinicalTrials.gov Identifier: NCT03531749     History of Changes
Other Study ID Numbers: FSSA2016051
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Antioxidants
Ascorbic Acid
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances