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CompletedNCT03531749Updated May 22, 2018

Antioxidant in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate

An interventional study of HIV+ MRPJ and HIV+ ascorbic acid in HIV Positive, sponsored by Universidad Autónoma del Estado de Hidalgo. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-22.

Sponsored by Universidad Autónoma del Estado de Hidalgo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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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.

Read the 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

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Conditions studied

  • HIV Positive

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03

In context

HIV Seropositivity

210 studies on the registry are indexed under HIV Seropositivity; 10 are open to participants now.

This study's enrollment of 60 is below the median of 89 across 140 interventional studies indexed under HIV Seropositivity.

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Lead sponsor

Universidad Autónoma del Estado de Hidalgo is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    HIV+ MRPJ

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

    Dietary Supplement: HIV+ MRPJ

  • Experimental
    HIV+ ascorbic acid

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

    Dietary Supplement: HIV+ ascorbic acid

  • Experimental
    HIV- MRPJ

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

    Dietary Supplement: HIV+ MRPJ

  • Experimental
    HIV- ascorbic acid

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

    Dietary Supplement: HIV+ ascorbic acid

  • No intervention
    HIV- Control

    Unsupplemented

  • No intervention
    HIV+ Control

    Unsupplemented

Interventions

  • Dietary supplementHIV+ MRPJ

    supplemented with (1g/d) MRPJ

  • Dietary supplementHIV+ ascorbic acid

    Supplemented with (1g/d) AA

06

What researchers measure

Primary outcomes

  1. Biochemical analyses to determine antioxidant capacity

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

    Time frame: At 0 time (baseline)

Secondary outcomes

  1. Biochemical analyses to determine antioxidant capacity

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

    Time frame: 30 days after intervention

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03531749
Lead sponsor
Universidad Autónoma del Estado de Hidalgo
Collaborators
National Council of Science and Technology, Mexico
Responsible party
Gabriel Betanzos Cabrera (Professor-Researcher, Universidad Autónoma del Estado de Hidalgo) — Principal investigator
First posted
May 22, 2018
Start date
Jan 2017
Primary completion
May 2017
Completion
May 2017
Last update
May 22, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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