Ketogenic Intervention in Depression

Last updated: May 28, 2025
Sponsor: Ohio State University
Overall Status: Completed

Phase

N/A

Condition

Depression

Treatment

Ketogenic Diet

gradCPT

WHO-5

Clinical Study ID

NCT06080932
2022H0271
  • Ages 18-30
  • All Genders
  • Accepts Healthy Volunteers

Study 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 program has any benefit on mental and metabolic health.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • OSU students (age 18-30 years at the time of enrollment) with confirmed majordepressive 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 foodsas prescribed

Exclusion

Exclusion Criteria:

  • Disordered eating, as evidenced by meeting criteria for Anorexia Nervosa, BulimiaNervosa, Binge Eating Disorder, Other Specified Eating Disorder, Unspecified EatingDisorder, or Avoidant Restrictive Eating Disorder during the SCID-5 interview atbaseline 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 prescribeddiets

  • Alcohol consumption in excess of 3 drinks/daily or 14 drinks/weekly

  • Diagnosed diabetes, liver, kidney, or other metabolic or endocrine dysfunction, oruse 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/ketonemonitoring

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.).

Study Design

Total Participants: 30
Treatment Group(s): 13
Primary Treatment: Ketogenic Diet
Phase:
Study Start date:
February 20, 2023
Estimated Completion Date:
December 21, 2024

Study 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 prevalence of symptoms of depression spiked from 6.5 to 24.3% , which was largely attributed to the COVID-19 pandemic. Major depression and suicidal ideation have increased markedly in young adults, particularly within college campuses. In 2020, counselors at the Ohio State University (OSU) experienced a surge in the number of students with various mental health issues with anxiety and depressive disorders being the most common. The escalating prevalence of depression bubbling under the surface of the ongoing COVID-19 pandemic represents a unique challenge that requires new and creative solutions.

Recently, a KD was administered to adults who had been admitted to a psychiatric hospital and were suffering from various mental disorders. The dietary intervention lasted between 16 and 248 days and showed significant improvements in depression and psychotic symptoms. Ketogenic diet interventions (and ingestion of ketone esters) have also been associated with more stable brain networks, assess with functional Magnetic Resonance Imaging (fMRI). Additionally, a novel but as yet under-appreciated effect of nutritional ketosis is to induce a broad-spectrum reduction in inflammation in metabolically-impaired individuals. Elevations in a range of inflammation biomarkers has been associated with severity of depression.

Although KDs have been proposed as a treatment option for mental health disorders, including schizophrenia and depression, few human clinical trials have tested the efficacy of this eating pattern specifically in a population of adults with major depression. In patients with type 2 diabetes (n=262) prescribed a KD using a novel virtual care model (Virta Health), we observed significant improvements in depressive symptoms after 10-weeks, which were directly correlated with the degree of carbohydrate restriction and nutritional ketosis as assessed by blood concentrations of ketones.

Connect with a study center

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

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