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临床试验/NCT03531749
NCT03531749已完成不适用

Antioxidant Activity and Lipid Peroxidation Status in Patients HIV+ Supplemented With Microencapsulated of Red Pomegranate

Universidad Autónoma del Estado de Hidalgo0 个研究点目标入组 60 人开始时间: 2017年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Biochemical analyses to determine antioxidant capacity

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

盲法说明

A prospective double-blind, randomized clinical trial of microencapsulated of red pomegranate to treat HIV-infected patients

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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

研究组 & 干预措施

HIV+ MRPJ

Experimental

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

干预措施: HIV+ MRPJ (Dietary Supplement)

HIV+ ascorbic acid

Experimental

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

干预措施: HIV+ ascorbic acid (Dietary Supplement)

HIV- MRPJ

Experimental

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

干预措施: HIV+ MRPJ (Dietary Supplement)

HIV- ascorbic acid

Experimental

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

干预措施: HIV+ ascorbic acid (Dietary Supplement)

HIV- Control

No Intervention

Unsupplemented

HIV+ Control

No Intervention

Unsupplemented

结局指标

主要结局

Biochemical analyses to determine antioxidant capacity

时间窗: At 0 time (baseline)

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

次要结局

  • Biochemical analyses to determine antioxidant capacity(30 days after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriel Betanzos Cabrera

Professor-Researcher

Universidad Autónoma del Estado de Hidalgo

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