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Ketogenic Intervention for Bipolar Depression

NCT07121894 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-26

No results posted yet for this study

Summary

The purpose of this study is to assess the clinical correlates of therapeutic precision ketosis in bipolar depression and to evaluate the cardiometabolic correlates associated with therapeutic precision ketosis in bipolar depression.

Conditions

Interventions

BEHAVIORAL

Ketogenic Diet

Participants will initiate a modified ketogenic diet under structured, intensive guidance. Simultaneously, participants will attend weekly behavioral support interviews with a psychiatrist to monitor mental health and mood stability.

Sponsors & Collaborators

Principal Investigators

  • Kyla M. Lara-Breitinger, MD · Mayo Clinic

  • Mark Frye, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-12
Primary Completion
2028-12-31
Completion
2029-05-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07121894 on ClinicalTrials.gov