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

Not Applicable

Not yet recruiting

• Conditions: Medical Keto Diet

• Registration Number: NCT07116226
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2025-06-09
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-04
• Study First Posted: 2025-08-11
• Last Update Submitted: 2025-08-11
• Last Update Posted: 2025-08-13
• Study Start: 2025-09-01
• Primary Completion: 2025-12-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in individual competence in understanding the nutritional aspects and food selection of a medical keto diet. Competence will be measured by pre- and post-education and post- LlVE IT experience (optional)	12 weeks	This will be assessed with16 items answerable along a Visual Analog scale each with scores from 0-100mm with higher scores demonstrating better competence.

Trial Locations

Locations (1)

Maryland Psychiatric Research Center (MPRC); 🇺🇸 Catonsville, Maryland, United States