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

Neurocognitive Impairment Clinical Trial

Official title:

Effects of Docosahexanoic Acid on Neurocognitive Impairment in HIV-infected Patients: A Randomized, Double-blind, Placebo-controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04242004
• Other study ID #: IRB#2019-06-0759
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: October 30, 2019
• Est. completion date: May 1, 2020

Study information

• Verified date: January 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: May 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Neurocognitive Impairment

Intervention

Drug:
• 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).

Dietary Supplement:
• Soy oil capsules
The placebo was identical looking capsules that contained soy oil

Locations

Country	Name	City	State
China	Department of epidemiology, School of public health, Fudan University,	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive impairment	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	16 weeks
Primary	Gut microbiota	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)	16 weeks