Stanford University Department of Psychiatry & Behavioral Sciences
Stanford, California, 94305, United States
NCT Number: NCT03935854
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Stanford, California, 94305, United States
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, along with other psychiatric diseases schizophrenia, 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 16 weeks
Time frame: Baseline, 16 weeks
Heart rate recorded at 9 visits during study
Time frame: Baseline, 16 weeks
Blood pressure recorded at 9 visits during study
Time frame: Baseline, 16 weeks
Weight recorded at 9 visits during study
Time frame: Baseline, 16 weeks
waist circumference measured at 9 visits during study
Time frame: Baseline, 16 weeks
Body composition (SECA) recorded at 5 visits during study
Time frame: Baseline, 16 weeks
Body composition (SECA) recorded at 5 visits during study
Time frame: Baseline, 16 weeks
Hemoglobin A1c recorded at initial and final visits
Time frame: Baseline, 16 weeks
HOMA-IR measured at initial and final visits
Time frame: Baseline, 16 weeks
hsCRP measured at initial and final visits
Time frame: Baseline, 16 weeks
Lipid profile TG measured at initial and final visits
Time frame: Baseline, 16 weeks
Lipid profile small LDL measured at initial and final visits
Time frame: Baseline,16 weeks
Lipid profile HDL measured at initial and final visits
Time frame: Baseline, 16 weeks
Change in Mood Qualitative Score (Clinical Mood Monitoring) from baseline
Time frame: Baseline, 16 weeks
Change in Clinical Global Impression Scales (CGI) from baseline 1-7 scale. 1= not at all ill, 7= among the most extremely ill patients)
Time frame: Baseline, 16 weeks
Change in Generalized Anxiety Symptom (GAD-7) scale from baseline. 0-15+ scale. (0= no anxiety, 15+= severe anxiety)
Time frame: Baseline, 16 weeks
Change in Patient Health Questionnaire (PHQ-9) from baseline. Score range 0-27 (0= no depression, 27= severe depression)
Time frame: Baseline, 16 weeks
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, 16 weeks
Change in Manchester Quality of Life Scale (MANSA) 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, 16 weeks
Change in Brief Psychiatric Rating Scale (BPRS) from baseline. Score range 18-126. (For each of 18 symptoms, 1=symptom not present, 7= extremely severe)
Time frame: Baseline, 16 weeks
Change in Pittsburgh Sleep Quality Index from baseline. 0-21 scale (<5=good sleeper; 5+= meaningfully disturbed sleep or poor sleeper)
Stanford University
Other
Impact of A Low-Carbohydrate, High-Fat, Ketogenic Diet on Obesity, Metabolic Abnormalities and Psychiatric Symptoms in Patients With Bipolar or Schizophrenia Illness: A Pilot Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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