COMPLETED

Ketogenic Intervention in Depression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Ketogenic Intervention in Depression

Quick Facts

Study Start:2023-02-20

Study Completion:2024-12-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06080932

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Study Locations (Sites)

The Ohio State University

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-20

Study Completion Date2024-12-21

Study Record Updates

Study Start Date2023-02-20

Study Completion Date2024-12-21

Terms related to this study

Additional Relevant MeSH Terms

Depression
Ketosis