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Learning How to Implement and Use a Ketogenic Diet to Improve Mental Health

NCT ID: NCT07116226

Last Updated: 2025-11-12

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-07-01

Brief Summary

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The goal of the study is to implement a team-based "train the trainer" group approach by providing participants education and the opportunity for self-implementing a medical ketogenic diet study for 4 weeks.

The overarching goal of the program is for those participating to be able to initiate the diet in clinical and research settings with greater competence.

The study has two parts:

1. Mastery Class (Education, Q \& A)
2. 4 Week Open Label LIVE IT ketogenic diet participation with private and group consultation (optional)

Detailed Description

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There will be two parts to assist with a train the trainer approach: 1) an educational component (4-hour mastery class, 2 Q\&A 1.5 hours) with related materials and 2) an open label cohort study providing the opportunity for participants to attempt the medical ketogenic diet within a group for 4 weeks with private and group counseling.

By participating in a 4-week self-implemented diet within a group setting our hope is to increase competence in implementing the diet and monitoring its success with KetoMojo. Secondarily, those who participate in the cohort study may have improvements in their own physical health and mental well-being.

After the 4 hour mastery class is completed an additional two weeks is given prior to the group keto diet starting to ensure all dietician meetings are completed.

Conditions

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Medical Keto Diet

Keywords

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Medical Ketogenic Diet

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Medical Keto Mastery Class

Group Type EXPERIMENTAL

Medical Keto Education Program

Intervention Type OTHER

4 hour asynchronous educational class

Interventions

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Medical Keto Education Program

4 hour asynchronous educational class

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ages 18-74 years
* Not currently on a ketogenic diet
* No prior experience in successfully implementing a medical ketogenic diet for self
* Clinician, researcher or clinical or research team member

Exclusion Criteria

* Age 18-74 years
* Body mass index \> 18.5
* Not currently on a ketogenic diet (Self report)
* No prior experience in successfully implementing a medical ketogenic diet for self (Self report)
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Deanna Kelly

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deanna L Kelly, PharmD, BCPP

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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Maryland Psychiatric Research Center (MPRC)

Catonsville, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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HP-00113852

Identifier Type: -

Identifier Source: org_study_id