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Antioxidant in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate

Primary Purpose

HIV Positive

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HIV+ MRPJ
HIV+ ascorbic acid
Sponsored by
Universidad Autónoma del Estado de Hidalgo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Positive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    No Intervention

    No Intervention

    Arm Label

    HIV+ MRPJ

    HIV+ ascorbic acid

    HIV- MRPJ

    HIV- ascorbic acid

    HIV- Control

    HIV+ Control

    Arm Description

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

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

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

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

    Unsupplemented

    Unsupplemented

    Outcomes

    Primary Outcome Measures

    Biochemical analyses to determine antioxidant capacity
    Four different tests for antioxidant activity were utilized. Plasma antioxidant capacity, catalase, H2O2, and TBARS

    Secondary Outcome Measures

    Biochemical analyses to determine antioxidant capacity
    Four different tests for antioxidant activity were utilized. Plasma antioxidant capacity, catalase, H2O2, and TBARS

    Full Information

    First Posted
    November 1, 2017
    Last Updated
    May 8, 2018
    Sponsor
    Universidad Autónoma del Estado de Hidalgo
    Collaborators
    National Council of Science and Technology, Mexico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03531749
    Brief Title
    Antioxidant in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate
    Official Title
    Antioxidant Activity and Lipid Peroxidation Status in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    May 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Autónoma del Estado de Hidalgo
    Collaborators
    National Council of Science and Technology, Mexico

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Positive

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A prospective double-blind randomized clinical trial
    Masking
    ParticipantInvestigator
    Masking Description
    A prospective double-blind, randomized clinical trial of microencapsulated of red pomegranate to treat HIV-infected patients
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HIV+ MRPJ
    Arm Type
    Experimental
    Arm Description
    Supplementation with microencapsulated (1g/d) for 90 days
    Arm Title
    HIV+ ascorbic acid
    Arm Type
    Experimental
    Arm Description
    Supplementation with ascorbic acid (1g/d) for 90 days
    Arm Title
    HIV- MRPJ
    Arm Type
    Experimental
    Arm Description
    Supplementation with microencapsulated (1g/d) for 90 days
    Arm Title
    HIV- ascorbic acid
    Arm Type
    Experimental
    Arm Description
    Supplementation with ascorbic acid (1g/d) for 90
    Arm Title
    HIV- Control
    Arm Type
    No Intervention
    Arm Description
    Unsupplemented
    Arm Title
    HIV+ Control
    Arm Type
    No Intervention
    Arm Description
    Unsupplemented
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    HIV+ MRPJ
    Intervention Description
    supplemented with (1g/d) MRPJ
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    HIV+ ascorbic acid
    Intervention Description
    Supplemented with (1g/d) AA
    Primary Outcome Measure Information:
    Title
    Biochemical analyses to determine antioxidant capacity
    Description
    Four different tests for antioxidant activity were utilized. Plasma antioxidant capacity, catalase, H2O2, and TBARS
    Time Frame
    At 0 time (baseline)
    Secondary Outcome Measure Information:
    Title
    Biochemical analyses to determine antioxidant capacity
    Description
    Four different tests for antioxidant activity were utilized. Plasma antioxidant capacity, catalase, H2O2, and TBARS
    Time Frame
    30 days after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Antioxidant in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate

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