Effects of Docosahexanoic Acid on Neurocognitive Impairment in HIV-infected Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2020-05-01

Brief Summary

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Neurocognitive impairment (NCI) is one of the serious complications of elderly HIV-infected patients. The destruction of intestinal mucosal barrier and imbalance of bacterial flora caused by aging and HIV infection may be an important factor promoting the occurrence of NCI. Therefore, it is important to understand changes in gut microbiota of HIV-infected patients with NCI. Higher dietary intake of the essential fatty acid docosahexaenoic (DHA) has been associated with better cognitive performance in several epidemiological studies. To date, data are limited showing that DHA administration leads to benefits for behavioral disorders by modulating gut microbiota composition; the few studies on this subject, mostly completed in animal models. Moreover，low levels of DHA have been found in HIV-infected patients. The effect of DHA supplementation on gut microbiota and NCI status of HIV-positive patients have not been evaluated yet. Investigators aim to implement a case-control study to identify the relationship between gut microbiota and NCI in HIV-infected patients. At the meantime, investigators aim to implement a randomized, double-blind, placebo-controlled clinical trial to assess DHA supplementation in HIV-infected patients with NCI for 16 weeks. The effect of DHA on gut microbiota and NCI were evaluated. Also, investigators aim to identify if the benefits for NCI of DHA caused by modulating gut microbiota composition and metabolites.

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Detailed Description

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Conditions

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Neurocognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization (1:1) was performed according to a computer-generated random sequence, which was used to allocate the participants either to the dietary supplement or the placebo group.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Participants, and investigators assessing outcome measures were blind to the intervention condition. Blinding was maintained until data analysis was completed.

Study Groups

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DHA group

Group Type EXPERIMENTAL

Docosahexaenoic acid (DHA) capsules

Intervention Type DRUG

Treatment was provided as 7 omega-3 fatty acid (Lovaza) capsules daily. Each capsule contained 1 g of omega-3 fatty acids with approximately 450 mg of docosahexaenoic acid (DHA).

placebo group

Group Type PLACEBO_COMPARATOR

Soy oil capsules

Intervention Type DIETARY_SUPPLEMENT

The placebo was identical looking capsules that contained soy oil

Interventions

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Docosahexaenoic acid (DHA) capsules

Treatment was provided as 7 omega-3 fatty acid (Lovaza) capsules daily. Each capsule contained 1 g of omega-3 fatty acids with approximately 450 mg of docosahexaenoic acid (DHA).

Intervention Type DRUG

Soy oil capsules

The placebo was identical looking capsules that contained soy oil

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Male and female patients
* Age ≥18 years
* Established diagnosis of HIV-1 infection, under stable cART for the prior 6 months and throughout the study period
* Presence of neurocognitive impairment was assessed using the global deficit score (GDS), calculated as the average of deficit scores across all neuropsychological test. The cut-off for NCI was a GDS score ≥ 0.5

Exclusion Criteria

* Age \<18 years,
* BMI \>30 kg/m2
* Pregnancy or lactation
* A history of diabetes mellitus, cardiovascular and cerebrovascular diseases, or serious diseases such as liver, kidney and hematopoietic system disease
* Known intolerance to n-3 PUFA preparations.

Eligible Sex

ALL

Accepts Healthy Volunteers

No