Trial Outcomes & Findings for Effects of Diet on Brain Processing (NCT NCT02835820)

NCT ID: NCT02835820

Last Updated: 2019-12-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: baseline
• Results posted on: 2019-12-16

Participant Flow

Participant milestones

Measure	Ketogenic Diet Group Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet Control. Participants maintained normal dietary behaviors
Overall Study STARTED	7	10
Overall Study Baseline Screen (OGTT)	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	Ketogenic Diet Group Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet Control. Participants maintained normal dietary behaviors
Overall Study Baseline Screen Failure	0	3

Baseline Characteristics

Effects of Diet on Brain Processing

Baseline characteristics by cohort

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Patient Choice Diet n=7 Participants Consumes regular diet/no diet restrictions	Total n=14 Participants Total of all reporting groups
Age, Continuous	56.7 years STANDARD_DEVIATION 5.7 • n=5 Participants	54.3 years STANDARD_DEVIATION 4.7 • n=7 Participants	55.5 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants
Food Insecurity	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

Population: Three participants from the PCD ineligible due to baseline screen fail.

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.

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at Baseline	29.4 score on a scale Standard Deviation 9.8	31.1 score on a scale Standard Deviation 8.6

PRIMARY outcome

Timeframe: baseline to week 12

Population: Three PCD participants ineligible due to baseline screen fail.

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.

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at 12 Weeks Post Baseline	35.3 score on a scale Standard Deviation 9.6	34.9 score on a scale Standard Deviation 12.6

PRIMARY outcome

Timeframe: baseline to week 18

Population: Three PCD participants ineligible due to baseline screen fail.

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.

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Neurocognition: Mean Score of Hopkins Verbal Learning Test at 18 Weeks Post Baseline	39.6 score on a scale Standard Deviation 9.1	36.6 score on a scale Standard Deviation 11.7

PRIMARY outcome

Timeframe: baseline

Population: Three PCD participants ineligible due to baseline screen fail.

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

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at Baseline	46.1 score on a scale Standard Deviation 9.3	46.0 score on a scale Standard Deviation 7.5

PRIMARY outcome

Timeframe: baseline to 12 weeks

Population: Three PCD participants ineligible due to baseline screen fail.

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

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 12 Weeks Post Baseline	46.7 score on a scale Standard Deviation 8.1	46.1 score on a scale Standard Deviation 9.5

PRIMARY outcome

Timeframe: baseline to 18 weeks

Population: Three PCD participants ineligible due to baseline screen fail.

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

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 18 Weeks Post Baseline	52.0 score on a scale Standard Deviation 10.8	44.7 score on a scale Standard Deviation 10.2

PRIMARY outcome

Timeframe: baseline

Population: Three PCD participants ineligible due to baseline screen fail.

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.

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Neurocognition: Mean Score of Trail Making A and B at Baseline	41.6 Seconds to complete Standard Deviation 17.0	50.0 Seconds to complete Standard Deviation 7.7

PRIMARY outcome

Timeframe: baseline to 12 weeks

Population: Three PCD participants ineligible due to baseline screen fail.

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.

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Neurocognition: Mean Score of Trail Making A and B at 12 Weeks Post Baseline	44.6 Seconds to complete Standard Deviation 17.6	44.3 Seconds to complete Standard Deviation 8.3

PRIMARY outcome

Timeframe: baseline to 18 weeks

Population: Three PCD participants ineligible due to baseline screen fail.

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.

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Neurocognition: Mean Score of Trail Making A and B at 18 Weeks Post Baseline	40.1 Seconds to complete Standard Deviation 16.2	44.1 Seconds to complete Standard Deviation 11.9

PRIMARY outcome

Timeframe: baseline

Population: Three PCD participants ineligible due to baseline screen fail.

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.

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Neurocognition: Mean Score of Stroop Test at Baseline	36.3 Number of correctly identified items Standard Deviation 6.8	36.0 Number of correctly identified items Standard Deviation 6.0

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Three PCD participants ineligible due to baseline screen fail.

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.

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Neurocognition: Mean Score of Stroop Test at 12 Weeks Post Baseline	40.0 Number of correctly identified items Standard Deviation 8.6	39.4 Number of correctly identified items Standard Deviation 6.2

PRIMARY outcome

Timeframe: baseline to 18 weeks

Population: Three PCD participants ineligible due to baseline screen fail.

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.

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Neurocognition: Mean Score of Stroop Test at 18 Weeks Post Baseline	39.1 Number of correctly identified items Standard Deviation 8.1	40.1 Number of correctly identified items Standard Deviation 6.3

PRIMARY outcome

Timeframe: baseline

Population: Three PCD participants were ineligible due to baseline screen fail.

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

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Cardiometabolic Markers: Mean Fasting Glucose Measures at Baseline	97.0 mg/dL Standard Deviation 1.4	101.4 mg/dL Standard Deviation 11.5

PRIMARY outcome

Timeframe: baseline to 12 weeks

Population: Three PCD participants were ineligible due to baseline screen fail.

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

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Cardiometabolic Markers: Mean Fasting Glucose Measures at 12 Weeks Post Baseline	98.1 mg/dL Standard Deviation 6.3	100.6 mg/dL Standard Deviation 16.6

PRIMARY outcome

Timeframe: baseline

Population: Three PCD participants were ineligible due to baseline screen fail.

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.

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Cardiometabolic Markers: Mean Markers of Inflammation (C-reactive Protein) Measures at Baseline	11.33 mg/L Standard Deviation 15.9	4.1 mg/L Standard Deviation 1.9

PRIMARY outcome

Timeframe: baseline to 12 weeks

Population: Three PCD participants were ineligible due to baseline screen fail.

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.

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Cardiometabolic Markers: Mean Markers of Inflammation (C-reactive Protein) Measures at 12 Weeks Post Baseline	9.1 mg/L Standard Deviation 10.2	3.6 mg/L Standard Deviation 3.5

PRIMARY outcome

Timeframe: baseline

Population: Three PCD participants were ineligible due to baseline screen fail.

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.

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Tumor Necrosis Factor Alpha (TNF or TNF-α)	2.9 pg/mL Standard Deviation 1.3	3.0 pg/mL Standard Deviation 1.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Ketogenic Diet Group n=7 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 Participants Control. Participants maintained normal dietary behaviors
Tumor Necrosis Factor (TNF or TNF-α)	2.7 pg/mL Standard Deviation 1.1	3.0 pg/mL Standard Deviation 0.9

SECONDARY outcome

Timeframe: baseline

Population: Those randomized to intervention group at baseline without MRI contraindications

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'

Outcome measures

Measure	Ketogenic Diet Group n=3 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet Control. Participants maintained normal dietary behaviors
Neural Activity: Presence or Absence of Impaired Bloodflow in the Brain at Baseline as Determined by a Functional MRI	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Intervention group as randomized.

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'

Outcome measures

Measure	Ketogenic Diet Group n=3 Participants Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet Control. Participants maintained normal dietary behaviors
Neural Activity: Presence or Absence of Impaired Bloodflow in the Brain at 12 Weeks Post Baseline as Determined by a Functional MRI	3 Participants	0 Participants

Adverse Events

Ketogenic Diet Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Participant Choice Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ketogenic Diet Group n=7 participants at risk Ketogenic meals (3 meals/day, 7 days/week x 12 weeks) prepared and delivered to participants. Ketogenic Diet: 12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.	Participant Choice Diet n=7 participants at risk Control. Participants maintained normal dietary behaviors
Respiratory, thoracic and mediastinal disorders Hospitalization	14.3% 1/7 • Number of events 1 • Adverse events data were collected across the 18 week study. One participant was admitted to hospital for asthma exacerbation.	0.00% 0/7 • Adverse events data were collected across the 18 week study. One participant was admitted to hospital for asthma exacerbation.

Additional Information

Shannon Morrison

University of Alabama at Birmingham

Phone: 12059967841

Email: samorris@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place