CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 17 enrolled
Drug / intervention
Ketogenic Dietdietary
Likely dose
Ketogenic diet (eucaloric, all meals/snacks provided) for 12 weeksAI-extracted
Key inclusion· 3
  • ✓HIV with CD4+ count >350 cells/mm³ for at least 2 years
  • ✓On current antiretroviral (cART) regimen for at least 6 months
  • ✓Mild to moderate cognitive impairment
Key exclusion· 6
  • ✕Current or recent drug or alcohol abuse
  • ✕History of Parkinson's disease
  • ✕History of Alzheimer's disease
  • ✕History of stroke or traumatic brain injury

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02835820
NCT02835820N/ACompleted
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The Effect of a Ketogenic Diet on HIV-Associated Neurocognitive Impairment

University of Alabama at Birmingham·interventional·Posted Jul 18, 2016·Updated Dec 16, 2019

In Brief

A clinical study evaluating Ketogenic Diet for HIV and Neurocognitive Impairment. Completed, enrolled 17 participants across 1 site.

Detailed Summary

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..

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, Neurocognitive Impairment
CountriesUnited States
CollaboratorsNational Center for Advancing Translational Sciences (NCATS), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 18, 2016
Enrollment StartApr 1, 2016
Primary CompletionJan 30, 2018
Study CompletionFeb 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.0 years ago

Interventions

Ketogenic Dietdietary

12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.