The Effect of a Ketogenic Diet on HIV-Associated Neurocognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at 12 Weeks Post Baseline
研究概览
简要总结
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..
详细描述
Specific Aims: In medically stable, older (> 50 years) HIV patients with cognitive impairment, this study will:
Overall: Test the feasibility of recruitment, retention, and adherence to a ketogenic diet versus patient choice diet (PCD) intervention.
Primary: Compare the impact of a 12-week KD versus PCD on:
- Cognitive function (at 12 weeks).
- Inflammation (at 12 weeks).
- Cardiometabolic profile (at 12 weeks).
- Persistence of cognitive effects (at 18 weeks).
Secondary: In a subsample (n = 5; experimental group): 5. Examine the changes in neural activity and neurocognitive functioning as demonstrated via magnetic resonance imaging (MRI), after a 12 week KD diet. 6. Assess the level of agreement between NIH Neurocognitive Tests and MRI in the assessment of neurocognitive functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Drug/alcohol abuse
- •History of Parkinsons
- •Alzheimers, stroke or traumatic brain injury
- •diabetes mellitus
- •renal insufficiency
结局指标
主要结局
Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at 12 Weeks Post Baseline
时间窗: baseline to week 12
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.
Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 18 Weeks Post Baseline
时间窗: baseline to 18 weeks
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
Neurocognition: Mean Score of Trail Making A and B at Baseline
时间窗: 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.
Neurocognition: Mean Score of Trail Making A and B at 12 Weeks Post Baseline
时间窗: baseline to 12 weeks
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.
Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at Baseline
时间窗: 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
Neurocognition: Mean Score of Stroop Test at Baseline
时间窗: 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.
Cardiometabolic Markers: Mean Fasting Glucose Measures at Baseline
时间窗: 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
Cardiometabolic Markers: Mean Fasting Glucose Measures at 12 Weeks Post Baseline
时间窗: baseline to 12 weeks
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
Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at Baseline
时间窗: 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.
Neurocognition: Mean Score of Hopkins Verbal Learning Test at 18 Weeks Post Baseline
时间窗: baseline to week 18
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.
Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 12 Weeks Post Baseline
时间窗: baseline to 12 weeks
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
Neurocognition: Mean Score of Trail Making A and B at 18 Weeks Post Baseline
时间窗: baseline to 18 weeks
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.
Neurocognition: Mean Score of Stroop Test at 12 Weeks Post Baseline
时间窗: Baseline to 12 weeks
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.
Cardiometabolic Markers: Mean Markers of Inflammation (C-reactive Protein) Measures at Baseline
时间窗: 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.
Cardiometabolic Markers: Mean Markers of Inflammation (C-reactive Protein) Measures at 12 Weeks Post Baseline
时间窗: baseline to 12 weeks
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.
Tumor Necrosis Factor Alpha (TNF or TNF-α)
时间窗: baseline
Tumor Necrosis Factor Alpha (TNF or TNF-α) is a major pro-inflammatory cytokine involved in inflammatory events. Being one of the most important pro-inflammatory cytokines, TNF-α 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.
Neurocognition: Mean Score of Stroop Test at 18 Weeks Post Baseline
时间窗: baseline to 18 weeks
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.
Tumor Necrosis Factor (TNF or TNF-α)
时间窗: baseline to week 12
Tumor Necrosis Factor Alpha (TNF or TNF-α) is a major pro-inflammatory cytokine involved in inflammatory events. Being one of the most important pro-inflammatory cytokines, TNF-α 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.
次要结局
- Neural Activity: Presence or Absence of Impaired Bloodflow in the Brain at Baseline as Determined by a Functional MRI(baseline)
- Neural Activity: Presence or Absence of Impaired Bloodflow in the Brain at 12 Weeks Post Baseline as Determined by a Functional MRI(Baseline to 12 weeks)
研究者
Shannon Morrison, PhD
Assistant Professor
University of Alabama at Birmingham