Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar Illness (NCT05705063) | Clinical Trial Compass
UnknownNot Applicable
Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar Illness
United States30 participantsStarted 2023-01-30
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female, 18 to 75 years of age.
✓. Able to provide informed consent.
✓. 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)
✓. 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.
✓. 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)
✓. In good general health, as ascertained by medical history.
✓. 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.
✓. willing to consent to all study procedures and attend follow-up appointments and motivated to follow dietary program.
Exclusion criteria
✕. Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
What they're measuring
1
Change in Weight from Baseline
Timeframe: Baseline, 6 weeks
2
Change in Waist Circumference from Baseline
Timeframe: Baseline, 6 weeks
3
Change in Heart Rate from Baseline
Timeframe: Baseline, 6 weeks
4
Change in Blood Pressure from Baseline
Timeframe: Baseline, 6 weeks
5
Change in Visceral Fat Mass from Baseline
Timeframe: Baseline, 6 weeks
6
Change in Body Fat Mass from Baseline
Timeframe: Baseline, 6 weeks
7
Change in Hemoglobin A1c from Baseline
Timeframe: Baseline, 6 weeks
8
Change in Insulin Resistance Measure (HOMA-IR) from Baseline
✕. Female with a positive pregnancy test at participation.
✕. comorbidity of developmental delay or Cognitive impairment (as noted by previous diagnoses-including dementia).
✕. 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.
✕. History of positive screening urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates.
✕. Current (or chronic) use of opiates.
✕. in a current severe mood or psychotic state when entering the study that would prohibit compliance with study visits or dietary program.
Change in Inflammatory Marker (hs-CRP) from Baseline