Clinical trial NCT06080932: Ketogenic Intervention in Depression
Official title: Ketogenic Intervention in Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Ketosis
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 program has any benefit on mental and metabolic health.

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 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.

Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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.).

Primary outcomes:
measure: WHO-5 Questionnaire
timeFrame: Up to ~ 12 weeks
measure: The Hamilton Depression Scale
timeFrame: Up to ~ 12 Weeks
measure: Finger Stick BHB
timeFrame: Up to ~ 12 Weeks
measure: Finger Stick Glucose
timeFrame: Up to ~ 12 Weeks
Secondary outcomes:
measure: PHQ-9
timeFrame: Up to ~ 12 Weeks
measure: CGM/CKM
timeFrame: Up to ~ 12 Weeks
measure: Metabolic Panel
timeFrame: Up to ~ 12 Weeks
measure: Blood Pressure
timeFrame: Up to ~ 12 Weeks
measure: Cognitive Testing
timeFrame: Up to ~ 12 Weeks
measure: Task-fMRI
timeFrame: Up to ~ 12 Weeks
measure: Resting State fMRI
timeFrame: Up to ~ 12 Weeks
measure: Lean Body Mass (kg)
timeFrame: Up to ~ 12 Weeks
measure: Changes in BMI
timeFrame: Up to ~ 12 Weeks
measure: Changes in total body weight ( kg)
timeFrame: Up to ~ 12 Weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References: