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Ketogenic Diet for Depression (KIND Trial)

Q: Is this clinical trial open to those aged sixty and above?

This particular clinical trial looks for participants aged between 18 and 30, but there are other studies that focus on different demographics: 218 trials involve minors and 1032 cater to those over 65.

Q: Is it possible to partake in this experiment?

Eligibility criteria for this trial require that participants have a diagnosed depressive disorder and are aged between 18-30. In total, 30 individuals must be recruited to complete the study.

Q: What is the scope of individuals being researched in this clinical investigation?

Indeed, clinicaltrials.gov has the latest information on this study which was initially posted in February of 2023 and most recently modified in October of that same year. The trial requires 30 enrollees from a solitary medical site to proceed.

Q: Are there any remaining vacancies for participants in this clinical trial?

As per the updated information on clinicaltrials.gov, this study is still open for recruitment. This particular trial was made available to participants on February 20th of 2021 and has since been revised as recently as October 6th of 2021.

Q: What results is the team hoping to achieve from this medical research?

The core measure of success for this clinical trial, which will be evaluated over a period up to 12 weeks, is the Hamilton <a href="https://www.withpower.com/clinical-trials/depression">Depression</a> Scale. Secondary metrics include changes in daily glucose and ketone levels (CGM/CKM), variations in metabolic blood panel (Metabolic Panel), and alterations to both systolic and diastolic blood pressure readings (Blood Pressure). Blood pressure measurements are documented using millimeters of mercury (mmHg); thus reading "120/80 mmHg" details an individual's respective systolic pressure at 120 mmHG with their diastolic measurement set at 80 mmHg.

N/A

Recruiting

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~ 12 weeks

Awards & highlights

KIND Trial Summary

This trial looks into using a ketogenic diet to help treat major depression and improve mental and metabolic health.

Who is the study for?

This trial is for Ohio State University students aged 18-30 with major depression, who are currently in counseling. Participants must be willing to follow a ketogenic diet for 12 weeks and not have eating disorders, diabetes, or other metabolic/endocrine dysfunctions. They can't be pregnant or at high risk of suicide.Check my eligibility

What is being tested?

The study tests if a ketogenic diet can help improve mental and metabolic health when added to the usual treatment program for depression. It includes monitoring body composition, mood scales (PHQ-9), cognitive tasks (gradCPT), brain imaging (fMRI), blood sugar/ketone levels, sleep quality, and overall well-being (WHO-5).See study design

What are the potential side effects?

Potential side effects from following a ketogenic diet may include digestive discomforts like constipation or diarrhea, initial fatigue or 'keto flu,' changes in blood sugar levels that could affect energy and mood, as well as possible nutrient deficiencies.

KIND Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an OSU student aged 18-30 with a confirmed diagnosis of major depressive disorder.

Select...

I am currently receiving counseling for depression.

KIND Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~ 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~ 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Finger Stick BHB

Finger Stick Glucose

The Hamilton Depression Scale

+1 more

Secondary outcome measures

Blood Pressure

CGM/CKM

Changes in BMI

+7 more

KIND Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketogenic DietExperimental Treatment13 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Blood Draw

2006

Completed Phase 4

~2400

WHO-5

2016

N/A

~70

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,590 Total Patients Enrolled

2 Trials studying Ketosis

415 Patients Enrolled for Ketosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial open to those aged sixty and above?

"This particular clinical trial looks for participants aged between 18 and 30, but there are other studies that focus on different demographics: 218 trials involve minors and 1032 cater to those over 65."

Answered by AI

Is it possible to partake in this experiment?

"Eligibility criteria for this trial require that participants have a diagnosed depressive disorder and are aged between 18-30. In total, 30 individuals must be recruited to complete the study."

Answered by AI

What is the scope of individuals being researched in this clinical investigation?

"Indeed, clinicaltrials.gov has the latest information on this study which was initially posted in February of 2023 and most recently modified in October of that same year. The trial requires 30 enrollees from a solitary medical site to proceed."

Answered by AI

Are there any remaining vacancies for participants in this clinical trial?

"As per the updated information on clinicaltrials.gov, this study is still open for recruitment. This particular trial was made available to participants on February 20th of 2021 and has since been revised as recently as October 6th of 2021."

Answered by AI

What results is the team hoping to achieve from this medical research?

"The core measure of success for this clinical trial, which will be evaluated over a period up to 12 weeks, is the Hamilton Depression Scale. Secondary metrics include changes in daily glucose and ketone levels (CGM/CKM), variations in metabolic blood panel (Metabolic Panel), and alterations to both systolic and diastolic blood pressure readings (Blood Pressure). Blood pressure measurements are documented using millimeters of mercury (mmHg); thus reading "120/80 mmHg" details an individual's respective systolic pressure at 120 mmHG with their diastolic measurement set at 80 mmHg."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ketogenic Intervention in Depression

2023. "Ketogenic Intervention in Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06080932.