Ketogenic Intervention in Depression (KIND)

The Ohio State University

Status

Enrolling

Conditions

Ketosis

Depression

Treatments

Behavioral: WHO-5

Behavioral: SKID

Other: NIH Toolbox

Biological: Ketone/Glucose Monitoring

Other: Body Composition

Other: CGM/CKM

Other: Resting-state fMRI

Other: Sleep Monitoring

Other: Ketogenic Diet

Other: gradCPT

Behavioral: PHQ-9

Other: Task-fMRI

Biological: Blood Draw

Study type

Interventional

Funder types

Other

Identifiers

NCT06080932

2022H0271

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.).

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Ketogenic Diet

Experimental group

Description:

The KD will follow general principles as we have described with the aim to achieve blood ketones \>0.5 mM, which will require most participants to consume \<50 g/day carbohydrate and \~1.5 g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.

Treatment: