Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2023-02-20
2024-12-21
Brief Summary
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Detailed Description
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Recently, a KD was administered to adults who had been admitted to a psychiatric hospital and were suffering from various mental disorders. The dietary intervention lasted between 16 and 248 days and showed significant improvements in depression and psychotic symptoms. Ketogenic diet interventions (and ingestion of ketone esters) have also been associated with more stable brain networks, assess with functional Magnetic Resonance Imaging (fMRI). Additionally, a novel but as yet under-appreciated effect of nutritional ketosis is to induce a broad-spectrum reduction in inflammation in metabolically-impaired individuals. Elevations in a range of inflammation biomarkers has been associated with severity of depression.
Although KDs have been proposed as a treatment option for mental health disorders, including schizophrenia and depression, few human clinical trials have tested the efficacy of this eating pattern specifically in a population of adults with major depression. In patients with type 2 diabetes (n=262) prescribed a KD using a novel virtual care model (Virta Health), we observed significant improvements in depressive symptoms after 10-weeks, which were directly correlated with the degree of carbohydrate restriction and nutritional ketosis as assessed by blood concentrations of ketones.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Ketogenic Diet
The KD will follow general principles as we have described with the aim to achieve blood ketones \>0.5 mM, which will require most participants to consume \<50 g/day carbohydrate and \~1.5 g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.
Ketogenic Diet
The diet intervention will start after all baseline testing is complete
NIH Toolbox
IPAD-based assessments that examines cognitive function
gradCPT
The gradCPT contains grayscale photographs of mountain scenes and city scenes. Scene images gradually transition from one image to the next
Resting-state fMRI
Whole brain echo-planar imaging (EPI) volumes sensitive to the BOLD signal will be acquired. Images will be re-aligned, un-warped, and normalized. Confounding effects of white matter, CSF signal, and head motion will be regressed from the functional time series, followed by bandpass filtering, linear detrending and smoothing, and whole brain resting state networks will be identified (e.g., default mode network, salience network, etc).
Task-fMRI
During whole brain EPI data acquisition, participants will be presented with words and pictures and asked to make judgements about the stimuli, such as indicating whether a particular stimulus (e.g., face-name association, word, number, or letter) has been previously presented, if a presented stimulus is a city or mountain scene, the direction an arrow is pointing (left or right), if a pair of stimuli match (e.g., faces with neutral or emotional expressions; word with a face). Behavioral responses will be recorded with an MRI compatible button box.
CGM/CKM
Continuous Ketone/Glucose Monitor will be applied at the start of Test Day 1. The sensor will be checked by the study team at each test day and will be removed and replaced by a fresh sensor at \~2- week intervals during the study. The sensor will be removed at the end of the final test day.
Blood Draw
Blood samples will be collected according to the schedule in Figure 1
Sleep Monitoring
Sleep will be assessed by ring-based acceleration with cloud technology (Oura Ring). This monitor is less burdensome than other sleep monitoring technologies and less likely to interfere with normal sleep and activity demands. Worn daily throughout intervention
Ketone/Glucose Monitoring
KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.
Body Composition
DEXA Scanning will be done pre-, mid-, and post- intervention.
PHQ-9
It is a self-assessment tool used to screen and assess the severity of depression in individuals. The PHQ-9 consists of nine questions based on the nine criteria for diagnosing major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
WHO-5
The WHO-5, also known as the World Health Organization-Five Well-Being Index, is a self-assessment tool used to measure subjective well-being and mental health. It was developed by the World Health Organization (WHO) as a brief and reliable instrument to evaluate well-being in clinical and research settings.
SKID
The SKID refers to the Structured Clinical Interview for DSM Disorders (SCID). It is a widely used diagnostic tool in the field of psychiatry and clinical psychology. The SCID is a semi-structured interview designed to assess and diagnose various mental disorders according to the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM), which is published by the American Psychiatric Association.
Interventions
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Ketogenic Diet
The diet intervention will start after all baseline testing is complete
NIH Toolbox
IPAD-based assessments that examines cognitive function
gradCPT
The gradCPT contains grayscale photographs of mountain scenes and city scenes. Scene images gradually transition from one image to the next
Resting-state fMRI
Whole brain echo-planar imaging (EPI) volumes sensitive to the BOLD signal will be acquired. Images will be re-aligned, un-warped, and normalized. Confounding effects of white matter, CSF signal, and head motion will be regressed from the functional time series, followed by bandpass filtering, linear detrending and smoothing, and whole brain resting state networks will be identified (e.g., default mode network, salience network, etc).
Task-fMRI
During whole brain EPI data acquisition, participants will be presented with words and pictures and asked to make judgements about the stimuli, such as indicating whether a particular stimulus (e.g., face-name association, word, number, or letter) has been previously presented, if a presented stimulus is a city or mountain scene, the direction an arrow is pointing (left or right), if a pair of stimuli match (e.g., faces with neutral or emotional expressions; word with a face). Behavioral responses will be recorded with an MRI compatible button box.
CGM/CKM
Continuous Ketone/Glucose Monitor will be applied at the start of Test Day 1. The sensor will be checked by the study team at each test day and will be removed and replaced by a fresh sensor at \~2- week intervals during the study. The sensor will be removed at the end of the final test day.
Blood Draw
Blood samples will be collected according to the schedule in Figure 1
Sleep Monitoring
Sleep will be assessed by ring-based acceleration with cloud technology (Oura Ring). This monitor is less burdensome than other sleep monitoring technologies and less likely to interfere with normal sleep and activity demands. Worn daily throughout intervention
Ketone/Glucose Monitoring
KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.
Body Composition
DEXA Scanning will be done pre-, mid-, and post- intervention.
PHQ-9
It is a self-assessment tool used to screen and assess the severity of depression in individuals. The PHQ-9 consists of nine questions based on the nine criteria for diagnosing major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
WHO-5
The WHO-5, also known as the World Health Organization-Five Well-Being Index, is a self-assessment tool used to measure subjective well-being and mental health. It was developed by the World Health Organization (WHO) as a brief and reliable instrument to evaluate well-being in clinical and research settings.
SKID
The SKID refers to the Structured Clinical Interview for DSM Disorders (SCID). It is a widely used diagnostic tool in the field of psychiatry and clinical psychology. The SCID is a semi-structured interview designed to assess and diagnose various mental disorders according to the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders (DSM), which is published by the American Psychiatric Association.
Eligibility Criteria
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Inclusion Criteria
* Currently engaged in counseling treatment for depression at CCS
* Available for a 12-week period and indicate willingness and ability to eat KD foods as prescribed
Exclusion Criteria
* Substantial imminent risk of suicide as assessed during the SCID-5 interview.
* Body mass index (BMI) \< 20 kg/m2
* Habitual consumption of a structured low-carbohydrate diet in the last 6-months
* Gastrointestinal disorders or allergies that would prevent adherence to prescribed diets
* Alcohol consumption in excess of 3 drinks/daily or 14 drinks/weekly
* Diagnosed diabetes, liver, kidney, or other metabolic or endocrine dysfunction, or use of diabetic medications other than metformin
* Inability to access or prepare appropriate KD foods/meals
* Pregnant, lactating, or planning on becoming pregnant during the study
* Unwilling to perform finger-stick blood testing or continuous glucose/ketone monitoring
Exclusion for optional MRI:
18 Years
30 Years
ALL
Yes
Sponsors
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Ohio State University
OTHER
Responsible Party
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Locations
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The Ohio State University
Columbus, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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2022H0271
Identifier Type: -
Identifier Source: org_study_id
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