Ketogenic Intervention in Depression

Summary

The goal of this study is to examine whether a well-formulated ketogenic diet (KD) can be implemented into a university counseling treatment program for major depression and to test whether such a program has any benefit on mental and metabolic health.

Conditions

• Depression
• Ketosis

Interventions

OTHER

Ketogenic Diet

The diet intervention will start after all baseline testing is complete

OTHER

NIH Toolbox

IPAD-based assessments that examines cognitive function

OTHER

gradCPT

The gradCPT contains grayscale photographs of mountain scenes and city scenes. Scene images gradually transition from one image to the next

OTHER

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).

OTHER

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.

OTHER

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.

BIOLOGICAL

Blood Draw

Blood samples will be collected according to the schedule in Figure 1

OTHER

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

BIOLOGICAL

Ketone/Glucose Monitoring

KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.

OTHER

Body Composition

DEXA Scanning will be done pre-, mid-, and post- intervention.

BEHAVIORAL

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).

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Ohio State University

  lead OTHER

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-20

Primary Completion

2024-06-01

Completion

2024-12-21

Countries

• United States

Study Locations