Neurocognitive Impairment
Conditions
Keywords
HIV-infected patients, neurocognitive impairment, gut microbiota, fatty acid docosahexaenoic, randomized controlled trial
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.
Interventions
DRUGDocosahexaenoic 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_SUPPLEMENTSoy oil capsules
The placebo was identical looking capsules that contained soy oil
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants, and investigators assessing outcome measures were blind to the intervention condition. Blinding was maintained until data analysis was completed.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Outcome results
None listed