Effects of Diet on Brain Processing

NCT02835820 | Completed Results

• 1 other identifier: HIV and Diet Study
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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..

Conditions

HIV; Neurocognitive Impairment

Keywords

HIV; Neurocognitive; Ketogenic Diet

Outcome Measures

Primary Outcomes (18)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Tumor Necrosis Factor Alpha (TNF or TNF-α)

  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.

  baseline

• Tumor Necrosis Factor (TNF or TNF-α)

  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.

  baseline to week 12

Secondary Outcomes (2)

• 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

Study Arms (2)

Ketogenic Diet Group

EXPERIMENTAL

Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants.

Dietary Supplement: Ketogenic Diet

Patient Choice Diet

NO INTERVENTION

Control.

Interventions

Ketogenic Diet DIETARY_SUPPLEMENT

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

Ketogenic Diet Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UAB 1917 Clinic

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Morrison SA, Fazeli PL, Gower B, Willig AL, Younger J, Sneed NM, Vance DE. Cognitive Effects of a Ketogenic Diet on Neurocognitive Impairment in Adults Aging With HIV: A Pilot Study. J Assoc Nurses AIDS Care. 2020 May-Jun;31(3):312-324. doi: 10.1097/JNC.0000000000000110.

  PMID: 31725105 DERIVED

MeSH Terms

Interventions

Diet, Ketogenic

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

Small sample size (pilot study), limited ability to monitor intervention fidelity, no reassessment until 12 weeks thus it is unclear as to when cognitive benefits emerged in persons randomized to the KD group.

Results Point of Contact

• Title: Shannon Morrison
• Organization: University of Alabama at Birmingham

samorris@uab.edu

12059967841

Study Officials

• Shannon Morrison, PhD

  Faculty

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: July 18, 2016
• Study Start: April 1, 2016
• Primary Completion: January 30, 2018
• Study Completion: February 15, 2019
• Last Updated: December 16, 2019
• Results First Posted: December 16, 2019

Record last verified: 2019-12

Locations

US (1)