Effects of Diet on Brain Processing

Completed · Not applicable

Conditions studied: HIV, Neurocognitive Impairment

In brief

Randomized control pilot 12 week feeding trial to compare the preliminary effects of ketogenic diet (versus patient choice diet) on HIV-associated neurocognitive impairment. N = 20 (n = 10/10) randomized to diet condition. Pilot data necessary to evaluate the feasibility and determine initial data for primary outcomes in order to accurately determine needed sample size for larger clinical trial. Outcomes: 1) cognition (NIH Toolkit), 2) cardiometabolic markers (insulin glucose, insulin resistance, markers of inflammation), and 3) neural activity (as determined by functional MRI..

Key facts

Study ID

NCT02835820

Run by

University of Alabama at Birmingham

People needed

17

Starts

2016-04-01

Expected to finish

2019-02-15

Last updated by the study team

2019-12-16

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stable HIV participants (CD4+ lymphocyte count > 350 cells/mm3) for at least two years
• prescribed their current cART regimen for at least six months) with mild to moderate cognitive impairment

You may not qualify if…

• Drug/alcohol abuse
• History of Parkinsons
• Alzheimers, stroke or traumatic brain injury
• diabetes mellitus
• renal insufficiency

Where it is running

• UAB 1917 Clinic — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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