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.
Adults with mental illness represent a high-risk, marginalized group in the current metabolic and obesity epidemic. Among US adults with severe mental illness, metabolic syndrome are highly prevalent conditions having severe consequences, with patients estimated to die on average 25 years earlier than the general population largely of premature cardiovascular disease. Many psychiatric medications, particularly neuroleptics and mood stabilizers, may, in addition, contribute to metabolic side effects and weight gain. Low-carbohydrate high-fat (LCHF) or ketogenic diets (KD) have been shown to reduce cardiovascular risk in those with insulin resistance. Recent findings support the idea that bipolar disorder may have roots of metabolic dysfunction: cerebral glucose hypometabolism, oxidative stress, as well as mitochondrial and neurotransmitter dysfunction which has downstream effects on synapse connections. A KD diet provides alternative fuel to the brain aside from glucose and is believed to contain beneficial neuroprotective effects, including stabilization of brain networks, reduction of inflammation and oxidative stress. The purpose of this study is to evaluate both the metabolic and psychiatric outcomes with a KD diet in this psychiatric population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 6 weeks
Stanford University School of Medicine
Stanford, California, United States
Change in Weight from Baseline
Weight recorded weekly during study
Time frame: Baseline, 6 weeks
Change in Waist Circumference from Baseline
Waist circumference recorded at each visit during study
Time frame: Baseline, 6 weeks
Change in Heart Rate from Baseline
Heart rate recorded at each visit during study
Time frame: Baseline, 6 weeks
Change in Blood Pressure from Baseline
Blood pressure recorded weekly during study
Time frame: Baseline, 6 weeks
Change in Visceral Fat Mass from Baseline
Kg visceral fat in body composition (SECA or Inbody) recorded 2-3 times during study
Time frame: Baseline, 6 weeks
Change in Body Fat Mass from Baseline
Kg body fat in body composition (SECA or Inbody) recorded 2-3 times during study
Time frame: Baseline, 6 weeks
Change in Hemoglobin A1c from Baseline
Blood measurement of Hemoglobin A1c recorded at baseline and study end
Time frame: Baseline, 6 weeks
Change in Insulin Resistance Measure (HOMA-IR) from Baseline
HOMA-IR calculated from blood measurements recorded at baseline and study end
Time frame: Baseline, 6 weeks
Change in Inflammatory Marker (hs-CRP) from Baseline
Blood measurement of hs-CRP recorded at baseline and study end
Time frame: Baseline, 6 weeks
Change in Lipid Profile (TG) from Baseline
Blood levels of Lipid Triglycerides (TG) recorded at baseline and study end
Time frame: Baseline, 6 weeks
Change in Lipid Profile small LDL from Baseline
Blood levels of small, low density lipoprotein cholesterol (LDL-C) recorded at baseline and study end
Time frame: Baseline, 6 weeks
Change in Lipid Profile HDL from Baseline
Blood levels of high density lipoprotein cholesterol (HDL-C) recorded at baseline and study end
Time frame: Baseline, 6 weeks
Change in Clinical Mood Monitoring from Baseline
Change in Clinical Mood Monitoring Psychiatric Index from Baseline
Time frame: Baseline, 6 weeks
Change in Clinical Global Impression from Baseline
Change in Clinical Global Impression (CGI) Psychiatric Index from Baseline; 1-7 scale. (1= not at all ill, 7= among the most extremely ill patients)
Time frame: Baseline, 6 weeks
Change Generalized Anxiety Disorder from Baseline
Change in General Anxiety Disorder (GAD-7) scale from Baseline. 0-15+ scale. (0= no anxiety, 15+= severe anxiety)
Time frame: Baseline, 6 weeks
Change in Depression from Baseline
Change in Depression on Patient Health Questionnaire (PHQ-9) scale from Baseline; Score range 0-27 (0= no depression, 27= severe depression)
Time frame: Baseline, 6 weeks
Change in Global Assessment of Functioning from Baseline
Change in Global Assessment of Functioning (GAF) scale from baseline; 1-100 scale (1= persistent danger of hurting self or others, 100= superior functioning)
Time frame: Baseline, 6 weeks
Change in Quality of Life from Baseline
Change in Manchester Quality of Life (MANSA) scale from baseline; Range 12-84 (each of 12 outcomes rated from 1= could not be worse to 7= could not be better; \<4= dissatisfied with QoL, \>4= satisfied with QoL)
Time frame: Baseline, 6 weeks
Change in Quality of Sleep from Baseline
Change in Pittsburgh Sleep Quality Index (PSQI) from baseline; 0-21 scale (\<5=good sleeper; 5+= meaningfully disturbed sleep or poor sleeper)
Time frame: Baseline, 6 weeks
Change in Eating Behavior from Baseline
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Change in Binge Eating Scale (BES) from Baseline; 0-46 scale (\<17 minimal binge eating problems, \>27 severe binge eating problems)
Time frame: Baseline, 6 weeks