N/A
Completed N=17
Effects of Diet on Brain Processing
Source: ClinicalTrials.gov NCT02835820 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at Baseline — 29.4; 31.1 score on a scale
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..
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 | — |
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
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. Informational only — not medical advice.