Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar or Schizo… (NCT03935854) | Clinical Trial Compass
CompletedNot Applicable
Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar or Schizophrenia Illness
United States23 participantsStarted 2019-02-13
Plain-language summary
To initiate a low-carbohydrate, high-fat (LCHF) or ketogenic dietary (KD) intervention among a cohort of outpatients with either schizophrenia or 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
✓. Age 18-75 years old
✓. Meet DSM V criteria for schizophrenia or bipolar disorder, any subtype, for \> 1 year and clinically stable (with no hospitalization for past 3 months)
✓. Currently taking 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)
✓. Willing to consent to all study procedures and attend follow-up appointments and motivated to follow the dietary program.
✓. Sufficient control over their food intake to adhere to study diets.
✓. Willingness to regularly monitor blood pressure, glucose, dietary intake, and body weight over the 4-month trial
Exclusion criteria
✕. Any subject pregnant or nursing
✕. Comorbidity of developmental delay
✕. Active substance abuse with illicit drugs or alcohol
✕. In a current severe mood or psychotic state when entering the study that would prohibit compliance with study visits or dietary program.
✕. Anyone who has been hospitalized or taken clozapine over the past 3 months
✕. Inability to complete baseline measurements
What they're measuring
1
Change in heart rate from baseline
Timeframe: Baseline, 16 weeks
2
Change in blood pressure from baseline
Timeframe: Baseline, 16 weeks
3
Change in weight from baseline
Timeframe: Baseline, 16 weeks
4
Change in waist circumference from baseline
Timeframe: Baseline, 16 weeks
5
Change in visceral fat mass from baseline
Timeframe: Baseline, 16 weeks
6
Change in body fat mass from baseline
Timeframe: Baseline, 16 weeks
7
Percent Change in Hemoglobin A1c from baseline
Timeframe: Baseline, 16 weeks
8
Change in insulin resistance measure (HOMA-IR) from baseline