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
About this trial
This is an interventional treatment trial for HIV Positive
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
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
NCT ID
NCT03531749
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
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
Learn more about this trial
Antioxidant in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate
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