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

Phase 1

• Conditions: Neurocognitive Impairment
• Interventions: Drug: Docosahexaenoic acid (DHA) capsules; Dietary Supplement: Soy oil capsules

• Registration Number: NCT04242004
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-10-30
• Status Verified: 2020-01
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-23
• Last Update Submitted: 2020-01-23
• Study First Posted: 2020-01-27
• Last Update Posted: 2020-01-27
• Primary Completion: 2020-03-01
• Study Completion: 2020-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHA group	Docosahexaenoic acid (DHA) capsules	-
placebo group	Soy oil capsules	-

Primary Outcome Measures

Name	Time	Method
Neurocognitive impairment	16 weeks	Participants underwent neurocognitive testing using an internationally validated comprehensive neurocognitive test battery covering 7 cognitive domains: verbal fluency, speed of information processing, executive functioning, learning, memory, attention/working memory and motor skills. Demographically-corrected (age, education, gender) T scores (mean of 50, standard deviation of 10) were developed based upon an age-matched control group. Individual test deficit scores, determined via demographically-adjusted T scores, ranged from 0 (T score of \> 40) to 5 (T score \< 20). Neurocognitive impairment (NCI) 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
Gut microbiota	16 weeks	Investigators characterized the 16S rDNA fecal microbiome in participants. Shannon diversity index (SDI) was used to evaluate alpha (within sample) diversity. Beta (between sample) diversity was examined using principle coordinate analysis (PCoA) of unweighted Unifrac distances. Relative abundance of microbial taxa was compared between samples using Linear Discriminant Analysis Effect Size (LEfSe)

Trial Locations

Locations (1)

Department of epidemiology, School of public health, Fudan University,; 🇨🇳 Shanghai, Shanghai, China