Status:
COMPLETED
Ketogenic Intervention in Depression
Lead Sponsor:
Ohio State University
Conditions:
Depression
Ketosis
Eligibility:
All Genders
18-30 years
Phase:
NA
Brief 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 pro...
Detailed Description
Major depression is a burgeoning problem that affects over five percent of adults worldwide and is rapidly increasing in the United States. From the second quarter of 2019 to June of 2020, the prevale...
Eligibility Criteria
Inclusion
- OSU students (age 18-30 years at the time of enrollment) with confirmed major depressive disorder as determined by SCID-5 diagnosis at baseline testing.
- 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
- Disordered eating, as evidenced by meeting criteria for Anorexia Nervosa, Bulimia Nervosa, Binge Eating Disorder, Other Specified Eating Disorder, Unspecified Eating Disorder, or Avoidant Restrictive Eating Disorder during the SCID-5 interview at baseline testing.
- 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:
- • The CCBBI screening form (https://redcap.osumc.edu/redcap/surveys/?s=N3XJ4WC7T9) will be used to assess MRI eligibility. Endorsement of items that contraindicate MRI will serve as exclusion criteria (pacemaker, stint, claustrophobia, etc.).
Key Trial Info
Start Date :
February 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06080932
Start Date
February 20 2023
End Date
December 21 2024
Last Update
May 29 2025
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43210