Clinical trial NCT04242004: Effects of Docosahexanoic Acid on Neurocognitive Impairment in HIV-infected Patients
Official title: Effects of Docosahexanoic Acid on Neurocognitive Impairment in HIV-infected Patients: A Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Neurocognitive Impairment
Keywords: HIV-infected patients
neurocognitive impairment
gut microbiota
fatty acid docosahexaenoic
randomized controlled trial
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Neurocognitive impairment
timeFrame: 16 weeks
measure: Gut microbiota
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of epidemiology, School of public health, Fudan University,
state: Shanghai
Study officials:
References:
citation: Dong R, Lin H, Ding Y, Chen X, Shi R, Yuan S, Li J, Zhu B, Xu X, Shen W, Wang K, Ding D, He N. Effects of Docosahexanoic Acid on Gut Microbiota and Fecal Metabolites in HIV-Infected Patients With Neurocognitive Impairment: A 6-Month Randomized, Double-Blind, Placebo-Controlled Trial. Front Nutr. 2022 Jan 21;8:756720. doi: 10.3389/fnut.2021.756720. eCollection 2021.