An interventional study of LCHF, Ketogenic Diet in Obesity, Ketogenic Dieting and Metabolic Syndrome, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 23 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cardiovascular dysfunction, including diagnosis of:
Patients follow ketogenic diet for 16 weeks, with monitoring of physical and psychological health and coaching support
Other: LCHF, Ketogenic Diet
Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 16 weeks
Change in heart rate from baseline
Heart rate recorded at 9 visits during study
Time frame: Baseline, 16 weeks
Change in blood pressure from baseline
Blood pressure recorded at 9 visits during study
Time frame: Baseline, 16 weeks
Change in weight from baseline
Weight recorded at 9 visits during study
Time frame: Baseline, 16 weeks
Change in waist circumference from baseline
waist circumference measured at 9 visits during study
Time frame: Baseline, 16 weeks
Change in visceral fat mass from baseline
Body composition (SECA) recorded at 5 visits during study
Time frame: Baseline, 16 weeks
Change in body fat mass from baseline
Body composition (SECA) recorded at 5 visits during study
Time frame: Baseline, 16 weeks
Percent Change in Hemoglobin A1c from baseline
Hemoglobin A1c recorded at initial and final visits
Time frame: Baseline, 16 weeks
Change in insulin resistance measure (HOMA-IR) from baseline
HOMA-IR measured at initial and final visits
Time frame: Baseline, 16 weeks
Change in inflammatory marker (hsCRP) from baseline
hsCRP measured at initial and final visits
Time frame: Baseline, 16 weeks
Change in lipid profile TG (triglycerides) from baseline
Lipid profile TG measured at initial and final visits
Time frame: Baseline, 16 weeks
Change in lipid profile small LDL (small dense LDL) from baseline
Lipid profile small LDL measured at initial and final visits
Time frame: Baseline, 16 weeks
Change in lipid profile (HDL) from baseline
Lipid profile HDL measured at initial and final visits
Time frame: Baseline,16 weeks
Psychiatric Indices - Mood
Change in Mood Qualitative Score (Clinical Mood Monitoring) from baseline
Time frame: Baseline, 16 weeks
Psychiatric Indices- Clinical Global Impression
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
Generalized Anxiety Disorder - GAD-7 Anxiety
Change in Generalized Anxiety Symptom (GAD-7) scale from baseline. 0-15+ scale. (0= no anxiety, 15+= severe anxiety)
Time frame: Baseline, 16 weeks
Patient Health Questionnaire - PHQ-9 Depression
Change in Patient Health Questionnaire (PHQ-9) from baseline. Score range 0-27 (0= no depression, 27= severe depression)
Time frame: Baseline, 16 weeks
Psychiatric Indices- Global Assessment of Functioning
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
Psychiatric Indices- Quality of Life
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
Psychiatric Indices- BPRS
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
Pittsburgh Sleep Quality Index - PSQI
Change in Pittsburgh Sleep Quality Index from baseline. 0-21 scale (\<5=good sleeper; 5+= meaningfully disturbed sleep or poor sleeper)
Time frame: Baseline, 16 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Brain Diseases, Metabolic
Stanford University