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LCHF Ketogenic Diet for Bipolar Disorder

N/A

Waitlist Available

Led By Shebani Sethi, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Meet DSM V criteria for diagnosis with Bipolar Disorder (BPD), any subtype, for > 1 year and clinically stable (with no hospitalization for past 3 months)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks

Awards & highlights

Study Summary

This trial will test if a low-carb, high-fat diet can improve health in people with bipolar disorder who are overweight or have metabolic problems.

Who is the study for?

This trial is for adults aged 18-75 with Bipolar Disorder who are generally healthy, not at risk of suicide, and can consent to study procedures. They should be clinically stable, possibly on certain psychiatric medications, and able to follow a ketogenic diet while monitoring health markers.Check my eligibility

What is being tested?

The trial tests the effects of a low-carbohydrate, high-fat ketogenic diet on patients with bipolar disorder who may also have metabolic issues or obesity. It aims to understand how this diet impacts both metabolic and psychiatric health over six weeks.See study design

What are the potential side effects?

Potential side effects from following a ketogenic diet might include flu-like symptoms (often called 'keto flu'), digestive changes like constipation or diarrhea, increased cholesterol levels, nutrient deficiencies if not properly managed, and possible mood fluctuations.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with Bipolar Disorder for over a year and have been stable with no hospital visits for 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 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

Change in Blood Pressure from Baseline

Change in Body Fat Mass from Baseline

Change in Heart Rate from Baseline

+9 more

Secondary outcome measures

Change Generalized Anxiety Disorder from Baseline

Change in Clinical Global Impression from Baseline

Change in Clinical Mood Monitoring from Baseline

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Bipolar PatientsExperimental Treatment1 Intervention

Patients follow ketogenic diet for 16 weeks, with monitoring of physical and psychological health and coaching support

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,386 Previous Clinical Trials

17,333,978 Total Patients Enrolled

Shebani Sethi, MDPrincipal InvestigatorStanford University Dept Psychiatry and Behavioral Sciences

1 Previous Clinical Trials

22 Total Patients Enrolled

Media Library

LCHF Ketogenic Diet (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05705063 — N/A

Brain Metabolic Syndrome Research Study Groups: Bipolar Patients

Brain Metabolic Syndrome Clinical Trial 2023: LCHF Ketogenic Diet Highlights & Side Effects. Trial Name: NCT05705063 — N/A

LCHF Ketogenic Diet (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05705063 — N/A

Frequently Asked Questions

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

Are there any age restrictions for enrollment in this experiment?

"The medical trial is inviting individuals aged 18 and older, but under the age of 75, to participate."

Answered by AI

Are there still opportunities for individuals to participate in this research?

"Clinicaltrials.gov has recorded that this medical study, which was initiated on the 30th of January 2023 and updated most recently a few days prior, is not presently enrolling patients. However, there are currently 2125 other trials open for patient recruitment."

Answered by AI

What are the desired outcomes of this medical experiment?

"The primary outcome measure for this trial, measured over a 6 week window from the Baseline, is alteration in waist circumference. Secondary metrics include changes in Clinical Mood Monitoring Psychiatric Index scores, General Anxiety Disorder (GAD-7) scale readings and Patient Health Questionnaire (PHQ-9) depression scales; with score ranges of 0-15+ and 0-27 respectively."

Answered by AI

Could I potentially be a part of the investigation?

"This medical experiment is in search of 30 individuals afflicted with bipolar disorder, aged between 18 and 75. Essential eligibility requirements are as follows: gender (male or female), informed consent, DSM V diagnosis for BPD sustained over at least one year without hospitalization within the past 3 months; participants may take SSRI antidepressant medication or other psychotropic drugs but must have been on a stable dose for four weeks prior to screening, BMI greater than 26 kg/m2 or 5% weight gain since beginning meds plus one metabolic abnormality; excellent general health confirmed via medical history; if female then non-childbearing status or valid birth control used"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar Illness

Shebani Sethi 2023. "Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar Illness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05705063.

All > Weight Gain > Bipolar Disorder