HIV PositiveNCT03531749
Antioxidant in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate
A study testing HIV+ MRPJ and HIV+ ascorbic acid in people with HIV Positive, run by Universidad Autónoma del Estado de Hidalgo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Positive
- What is being tested?
- HIV+ MRPJ and HIV+ ascorbic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Antioxidant Activity and Lipid Peroxidation Status in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate
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
- Conditions
- HIV Positive
- Being tested
- HIV+ MRPJ, HIV+ ascorbic acid
- Medical subject headings
- HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV+ MRPJDietary supplement
supplemented with (1g/d) MRPJ
HIV+ ascorbic acidDietary supplement
Supplemented with (1g/d) AA
| Study group | Role | What they receive |
|---|---|---|
| HIV+ MRPJ | Experimental | Supplementation with microencapsulated (1g/d) for 90 days Receives: Dietary Supplement: HIV+ MRPJ |
| HIV+ ascorbic acid | Experimental | Supplementation with ascorbic acid (1g/d) for 90 days Receives: Dietary Supplement: HIV+ ascorbic acid |
| HIV- MRPJ | Experimental | Supplementation with microencapsulated (1g/d) for 90 days Receives: Dietary Supplement: HIV+ MRPJ |
| HIV- ascorbic acid | Experimental | Supplementation with ascorbic acid (1g/d) for 90 Receives: Dietary Supplement: HIV+ ascorbic acid |
| HIV- Control | No intervention | Unsupplemented |
| HIV+ Control | No intervention | Unsupplemented |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical analyses to determine antioxidant capacity
Four different tests for antioxidant activity were utilized. Plasma antioxidant capacity, catalase, H2O2, and TBARS
Measured: 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
Measured: 30 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study startJan 2017
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective double-blind randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma del Estado de Hidalgo
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Responsible party
- Principal investigator, Gabriel Betanzos Cabrera, Universidad Autónoma del Estado de Hidalgo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531749
- Sponsor's protocol ID
- FSSA2016051
- Status last verified
- May 2018
- First submitted
- 1 Nov 2017
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antioxidant Activity and Lipid Peroxidation Status in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate
- ClinicalTrials.gov ID
- NCT03531749
- Acronym / sponsor ID
- FSSA2016051
- Conditions
- HIV Positive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Autónoma del Estado de HidalgoUniversity, hospital or other
- Collaborators
- National Council of Science and Technology, Mexico
- Study start
- Jan 2017
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- A prospective double-blind randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| HIV+ MRPJ | Experimental | Dietary Supplement: HIV+ MRPJSupplementation with microencapsulated (1g/d) for 90 days |
| HIV+ ascorbic acid | Experimental | Dietary Supplement: HIV+ ascorbic acidSupplementation with ascorbic acid (1g/d) for 90 days |
| HIV- MRPJ | Experimental | Dietary Supplement: HIV+ MRPJSupplementation with microencapsulated (1g/d) for 90 days |
| HIV- ascorbic acid | Experimental | Dietary Supplement: HIV+ ascorbic acidSupplementation with ascorbic acid (1g/d) for 90 |
| HIV- Control | No intervention | –Unsupplemented |
| HIV+ Control | No intervention | –Unsupplemented |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV+ MRPJsupplemented with (1g/d) MRPJ | Dietary supplement | HIV+ MRPJ, HIV- MRPJ |
| HIV+ ascorbic acidSupplemented with (1g/d) AA | Dietary supplement | HIV+ ascorbic acid, HIV- ascorbic acid |
Primary outcome
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
1 secondary outcome
Biochemical analyses to determine antioxidant capacity
Time frame: 30 days after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HIV+ MRPJ and HIV+ ascorbic acid in people with HIV Positive, run by Universidad Autónoma del Estado de Hidalgo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical analyses to determine antioxidant capacity (time frame: At 0 time (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.