N/A N=17 Randomized Treatment

Effects of Diet on Brain Processing

HIV · Neurocognitive Impairment

Bottom Line

View on ClinicalTrials.gov: NCT02835820 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2019

Primary outcome: Primary: Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at Baseline — 29.4; 31.1 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ketogenic Diet (Dietary_supplement)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Jan 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at Baseline	29.4; 31.1	—
PRIMARY Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at 12 Weeks Post Baseline	35.3; 34.9	—
PRIMARY Neurocognition: Mean Score of Hopkins Verbal Learning Test at 18 Weeks Post Baseline	39.6; 36.6	—
PRIMARY Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at Baseline	46.1; 46.0	—
PRIMARY Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 12 Weeks Post Baseline	46.7; 46.1	—
PRIMARY Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 18 Weeks Post Baseline	52.0; 44.7	—
PRIMARY Neurocognition: Mean Score of Trail Making A and B at Baseline	41.6; 50.0	—
PRIMARY Neurocognition: Mean Score of Trail Making A and B at 12 Weeks Post Baseline	44.6; 44.3	—
PRIMARY Neurocognition: Mean Score of Trail Making A and B at 18 Weeks Post Baseline	40.1; 44.1	—
PRIMARY Neurocognition: Mean Score of Stroop Test at Baseline	36.3; 36.0	—
PRIMARY Neurocognition: Mean Score of Stroop Test at 12 Weeks Post Baseline	40.0; 39.4	—
PRIMARY Neurocognition: Mean Score of Stroop Test at 18 Weeks Post Baseline	39.1; 40.1	—
PRIMARY Cardiometabolic Markers: Mean Fasting Glucose Measures at Baseline	97.0; 101.4	—
PRIMARY Cardiometabolic Markers: Mean Fasting Glucose Measures at 12 Weeks Post Baseline	98.1; 100.6	—
PRIMARY Cardiometabolic Markers: Mean Markers of Inflammation (C-reactive Protein) Measures at Baseline	11.33; 4.1	—
PRIMARY Cardiometabolic Markers: Mean Markers of Inflammation (C-reactive Protein) Measures at 12 Weeks Post Baseline	9.1; 3.6	—
PRIMARY Tumor Necrosis Factor Alpha (TNF or TNF-α)	2.9; 3.0	—
PRIMARY Tumor Necrosis Factor (TNF or TNF-α)	2.7; 3.0	—
SECONDARY Neural Activity: Presence or Absence of Impaired Bloodflow in the Brain at Baseline as Determined by a Functional MRI	3; 0	—
SECONDARY Neural Activity: Presence or Absence of Impaired Bloodflow in the Brain at 12 Weeks Post Baseline as Determined by a Functional MRI	3; 0	—

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..

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02835820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.