HIV Clinical Trial
— EDBPOfficial title:
The Effect of a Ketogenic Diet on HIV-Associated Neurocognitive Impairment
Verified date | December 2019 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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..
Status | Completed |
Enrollment | 17 |
Est. completion date | February 15, 2019 |
Est. primary completion date | January 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UAB 1917 Clinic | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham | National Center for Advancing Translational Science (NCATS), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at Baseline | The Hopkins Verbal Learning Test is used to measure episodic verbal learning and memory. The range of the score for the Hopkins Verbal Learning score is as follows: > 130 superior; 120-129 high; 110-119 bright, normal; 90-109 average; 85-89 low average; 70-84 borderline mental deficit; 35-49 moderate mental deficit; 20-34 severe mental deficit; 20-25 profound mental deficit. | baseline | |
Primary | Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at 12 Weeks Post Baseline | The Hopkins Verbal Learning Test is used to measure episodic verbal learning and memory. The range of the score for the Hopkins Verbal Learning score is as follows: > 130 superior; 120-129 high; 110-119 bright, normal; 90-109 average; 85-89 low average; 70-84 borderline mental deficit; 35-49 moderate mental deficit; 20-34 severe mental deficit; 20-25 profound mental deficit. | baseline to week 12 | |
Primary | Neurocognition: Mean Score of Hopkins Verbal Learning Test at 18 Weeks Post Baseline | The Hopkins Verbal Learning Test is used to measure episodic verbal learning and memory. The range of the score for the Hopkins Verbal Learning score is as follows: > 130 superior; 120-129 high; 110-119 bright, normal; 90-109 average; 85-89 low average; 70-84 borderline mental deficit; 35-49 moderate mental deficit; 20-34 severe mental deficit; 20-25 profound mental deficit. | baseline to week 18 | |
Primary | Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at Baseline | The Wechsler Adult Intelligence Scale is an II test to measure intelligence and cognitive ability. The Full Scale scores are: beyond 130 place an individual in the superior or gifted range; scores between 120-129 suggest very bright; scores between 110-119 are bright normal; scores as 90-109 are average; scores of 85-89 suggest average intelligence; score of 70-84 suggests low average intelligence; score of 50 - 69 suggests borderline mental functioning; score of 50 - 69 suggests mild mental retardation; score of 35-49 suggests moderate retardation; 20 - 34 suggests severe retardation; below 20 - 25 suggests profound retardation | baseline | |
Primary | Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 12 Weeks Post Baseline | The Wechsler Adult Intelligence Scale is an I! test to measure intelligence and cognitive ability. The Full Scale scores are: beyond 130 place an individual in the superior or gifted range; scores between 120-129 suggest very bright; scores between 110-119 are bright normal; scores as 90-109 are average; scores of 85-89 suggest average intelligence; score of 70-84 suggests low average intelligence; score of 50 - 69 suggests borderline mental functioning; score of 50 - 69 suggests mild mental retardation; score of 35-49 suggests moderate retardation; 20 - 34 suggests severe retardation; below 20 - 25 suggests profound retardation | baseline to 12 weeks | |
Primary | Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 18 Weeks Post Baseline | The Wechsler Adult Intelligence Scale is an I! test to measure intelligence and cognitive ability. The Full Scale scores are: beyond 130 place an individual in the superior or gifted range; scores between 120-129 suggest very bright; scores between 110-119 are bright normal; scores as 90-109 are average; scores of 85-89 suggest average intelligence; score of 70-84 suggests low average intelligence; score of 50 - 69 suggests borderline mental functioning; score of 50 - 69 suggests mild mental retardation; score of 35-49 suggests moderate retardation; 20 - 34 suggests severe retardation; below 20 - 25 suggests profound retardation | baseline to 18 weeks | |
Primary | Neurocognition: Mean Score of Trail Making A and B at Baseline | Trails A (simple) and Trails B (alternative) neuropsychological assessments provide information on cognitive processes such as visual search, scanning, speed of processing, mental flexibility, and executive functions (i.e., memory, problem solving, verbal reasoning). It is sensitive to cognitive impairment associated with dementia. The average score for trail making is 29 seconds. Scores over 78 seconds suggest a deficit. | baseline | |
Primary | Neurocognition: Mean Score of Trail Making A and B at 12 Weeks Post Baseline | Trails A (simple) and Trails B (alternative) neuropsychological assessments provide information on cognitive processes such as visual search, scanning, speed of processing, mental flexibility, and executive functions (i.e., memory, problem solving, verbal reasoning).It is sensitive to cognitive impairment associated with dementia. The average score for trail making is 29 seconds. Scores over 78 seconds suggest a deficit. | baseline to 12 weeks | |
Primary | Neurocognition: Mean Score of Trail Making A and B at 18 Weeks Post Baseline | Trails A (simple) and Trails B (alternative) neuropsychological assessments provide information on cognitive processes such as visual search, scanning, speed of processing, mental flexibility, and executive functions (i.e., memory, problem solving, verbal reasoning). It is sensitive to cognitive impairment associated with dementia. The average score for trail making is 29 seconds. Scores over 78 seconds suggest a deficit. | baseline to 18 weeks | |
Primary | Neurocognition: Mean Score of Stroop Test at Baseline | The score of greater than is considered normal; a score of 40 or less is considered "low" whereas a score greater than 40 is considered "normal". Stroop test is named after the instrument developer, John Stroop. The instrument title is not an acronym. |
baseline | |
Primary | Neurocognition: Mean Score of Stroop Test at 12 Weeks Post Baseline | The score of greater than is considered normal; a score of 40 or less is considered "low" whereas a score greater than 40 is considered "normal". Stroop test is named after the instrument developer, John Stroop. The instrument title is not an acronym. |
Baseline to 12 weeks | |
Primary | Neurocognition: Mean Score of Stroop Test at 18 Weeks Post Baseline | The STROOP measures brain damage. The score of greater than is considered normal; a score of 40 or less is considered "low" whereas a score greater than 40 is considered "normal". Stroop test is named after the instrument developer, John Stroop. The instrument title is not an acronym. |
baseline to 18 weeks | |
Primary | Cardiometabolic Markers: Mean Fasting Glucose Measures at Baseline | A fasting blood sugar level less than 100mg/dl is normal. A fasting blood sugar level of 100- 126mg/dl is considered prediabetic. 126mg/dl or greater suggests diabetes | baseline | |
Primary | Cardiometabolic Markers: Mean Fasting Glucose Measures at 12 Weeks Post Baseline | A fasting blood sugar level less than 100mg/dl is normal. A fasting blood sugar level of 100- 126mg/dl is considered prediabetic. 126mg/dl or greater suggests diabetes | baseline to 12 weeks | |
Primary | Cardiometabolic Markers: Mean Markers of Inflammation (C-reactive Protein) Measures at Baseline | C-reactive protein (CRP) , a protein in the blood, indicates inflammation, specifically in the heart.. CRP levels rise with inflammation. A CRP concentration of below 1.0 mg/L indicates low risk; 1.0 to 3.0 mg/L suggests an average risk. Greater than 3.0 mg/L suggests a high risk. | baseline | |
Primary | Cardiometabolic Markers: Mean Markers of Inflammation (C-reactive Protein) Measures at 12 Weeks Post Baseline | C-reactive protein (CRP) , a protein in the blood, indicates inflammation, specifically in the heart.. CRP levels rise with inflammation. A CRP concentration of below 1.0 mg/L indicates low risk; 1.0 to 3.0 mg/L suggests an average risk. Greater than 3.0 mg/L suggests a high risk. | baseline to 12 weeks | |
Primary | Tumor Necrosis Factor Alpha (TNF or TNF-a) | Tumor Necrosis Factor Alpha (TNF or TNF-a) is a major pro-inflammatory cytokine involved in inflammatory events. Being one of the most important pro-inflammatory cytokines, TNF-a participates in vasodilatation and edema formation, and leukocyte adhesion to epithelium through expression of adhesion molecules; it regulates blood coagulation, and also contributes to oxidative stress in sites of inflammation. | baseline | |
Primary | Tumor Necrosis Factor (TNF or TNF-a) | Tumor Necrosis Factor Alpha (TNF or TNF-a) is a major pro-inflammatory cytokine involved in inflammatory events. Being one of the most important pro-inflammatory cytokines, TNF-a participates in vasodilatation and edema formation, and leukocyte adhesion to epithelium through expression of adhesion molecules; it regulates blood coagulation, and also contributes to oxidative stress in sites of inflammation. | baseline to week 12 | |
Secondary | Neural Activity: Presence or Absence of Impaired Bloodflow in the Brain at Baseline as Determined by a Functional MRI | Functional MRI is used to determine blood flow in the brain. Absence of blood flow impairment will be recorded as '0' and impairment will be recorded as '1' | baseline | |
Secondary | Neural Activity: Presence or Absence of Impaired Bloodflow in the Brain at 12 Weeks Post Baseline as Determined by a Functional MRI | Functional MRI is used to determine blood flow in the brain. Absence of blood flow impairment will be recorded as '0' and impairment will be recorded as '1' | Baseline to 12 weeks |
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