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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
Must not have
Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study
Cardiovascular dysfunction, including diagnosis of: Congestive heart failure, Angina, Arrhythmias, Cardiomyopathy, Valvular heart disease, History of cardiovascular disease or cardiac event
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks
Awards & highlights
No Placebo-Only Group

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not willing to use birth control during the study.
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I have a history of heart problems.
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I have been hospitalized or taken clozapine at doses above 550mg in the last 3 months.
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I am not pregnant.
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I have severe kidney or liver problems.
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I have been diagnosed with a developmental delay or cognitive impairment.
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I am currently pregnant or breastfeeding.
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I cannot complete initial health measurements.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Blood Pressure from Baseline
Change in Body Fat Mass from Baseline
Change in Heart Rate from Baseline
+9 more
Secondary study objectives
Change Generalized Anxiety Disorder from Baseline
Change in Clinical Global Impression from Baseline
Change in Clinical Mood Monitoring from Baseline
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,472 Previous Clinical Trials
17,501,788 Total Patients Enrolled
70 Trials studying Obesity
270,164 Patients Enrolled for Obesity
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
Obesity Research Study Groups: Bipolar Patients
Obesity 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
~11 spots leftby Nov 2025
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