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
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2017
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
November 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 22, 2018
CompletedMay 22, 2018
May 1, 2018
4 months
November 1, 2017
May 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Biochemical analyses to determine antioxidant capacity
30 days after intervention
Study Arms (6)
HIV+ MRPJ
EXPERIMENTALSupplementation with microencapsulated (1g/d) for 90 days
HIV+ ascorbic acid
EXPERIMENTALSupplementation with ascorbic acid (1g/d) for 90 days
HIV- MRPJ
EXPERIMENTALSupplementation with microencapsulated (1g/d) for 90 days
HIV- ascorbic acid
EXPERIMENTALSupplementation with ascorbic acid (1g/d) for 90
HIV- Control
NO INTERVENTIONUnsupplemented
HIV+ Control
NO INTERVENTIONUnsupplemented
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- A prospective double-blind, randomized clinical trial of microencapsulated of red pomegranate to treat HIV-infected patients
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor-Researcher
Study Record Dates
First Submitted
November 1, 2017
First Posted
May 22, 2018
Study Start
January 1, 2017
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
May 22, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share