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Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar Illness
Trial ID: NCT05705063
To initiate a low-carbohydrate, high-fat (LCHF) or ketogenic dietary (KD) intervention among a cohort of outpatients with bipolar illness who also have metabolic abnormalities, overweight/obesity, and/or are currently taking psychotropic medications experiencing metabolic side effects.
Impact of A Low-Carbohydrate, High-Fat, Ketogenic Diet on Obesity, Metabolic Abnormalities, and Psychiatric Symptoms on Patients With Bipolar Disorder (BPD)
1. Male or female, 18 to 75 years of age.
2. Able to provide informed consent.
3. 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)
4. Participants may currently be on a stable and adequate dose of SSRI antidepressant
therapy or other psychiatric medications. Concurrent hypnotic therapy (e.g., with
zolpidem, zaleplon, melatonin, or trazodone) will be allowed if the therapy has been
stable for at least 4 weeks prior to screening and if it is expected to remain stable.
Participants may choose to not be on antidepressant therapy for the study duration, or
to be switched from other classes to a medication from the SSRI class.
5. currently taking SSRI or psychotropic medication and gained at least 5% weight since
starting medication or have a BMI greater than or equal to 26 kg/m2 or presence of at
least one metabolic abnormality (hypertriglyceridemia, insulin resistance,
dyslipidemia, impaired glucose tolerance)
6. In good general health, as ascertained by medical history.
7. If female, a status of non-childbearing potential or use of an acceptable form of
birth control. The form of birth control will be documented at screening and baseline.
8. willing to consent to all study procedures and attend follow-up appointments and
motivated to follow dietary program.
9. Sufficient control over their food intake to adhere to study diets.
10. willingness to regularly monitor blood pressure, glucose, dietary intake, and body
weight over 6-week trial
1. Female of childbearing potential who is not willing to use one of the specified forms
of birth control during the study.
2. Female that is pregnant or breastfeeding.
3. Female with a positive pregnancy test at participation.
4. comorbidity of developmental delay or Cognitive impairment (as noted by previous
5. Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by
DSM-IV-TR), with the exception of nicotine dependence, at screening or within six
months prior to screening.
6. History of positive screening urine test for drugs of abuse at screening: cocaine,
amphetamines, barbiturates, opiates.
7. Current (or chronic) use of opiates.
8. in a current severe mood or psychotic state when entering the study that would
prohibit compliance with study visits or dietary program.
9. Considered at significant risk for suicide during the course of the study.
10. any one who has been hospitalized or taken clozapine at doses above 550mg over the
past 3 months
11. Has a clinically significant abnormality on the screening examination that might
affect safety, study participation, or confound interpretation of study results.
12. Any current or past history of any physical condition which in the investigator's
opinion might put the subject at risk or interfere with study results interpretation.
13. Participation in any clinical trial with an investigational drug or device within the
past month or concurrent to study participation.
14. inability to complete baseline measurements
15. severe renal or hepatic insufficiency
16. cardiovascular dysfunction, including diagnosis of:
1. Congestive heart failure
5. Valvular heart disease
6. History of cardiovascular disease or cardiac event.
17. any other medical condition that may make either diet dangerous as determined by the
study medical team (e.g. anorexia nervosa)
other: LCHF Ketogenic Diet
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Diane E Wakeham, PhD