Skip to main content
OpenTrials
Completed

NCT Number: NCT03935854

Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar or Schizophrenia Illness

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Severe renal or hepatic insufficiency
  • Cardiovascular dysfunction, including diagnosis of:
  • Congestive heart failure
  • Angina
  • Arrhythmias
  • Cardiomyopathy
  • Valvular heart disease
  • Any other medical condition that may make either diet dangerous as determined by the study medical team (e.g. anorexia nervosa)

Treatment and study plan

LCHF, Ketogenic Diet

Other

Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 16 weeks

Primary outcomes

  1. Change in heart rate from baseline

    Time frame: Baseline, 16 weeks

    Heart rate recorded at 9 visits during study

  2. Change in blood pressure from baseline

    Time frame: Baseline, 16 weeks

    Blood pressure recorded at 9 visits during study

  3. Change in weight from baseline

    Time frame: Baseline, 16 weeks

    Weight recorded at 9 visits during study

  4. Change in waist circumference from baseline

    Time frame: Baseline, 16 weeks

    waist circumference measured at 9 visits during study

  5. Change in visceral fat mass from baseline

    Time frame: Baseline, 16 weeks

    Body composition (SECA) recorded at 5 visits during study

  6. Change in body fat mass from baseline

    Time frame: Baseline, 16 weeks

    Body composition (SECA) recorded at 5 visits during study

  7. Percent Change in Hemoglobin A1c from baseline

    Time frame: Baseline, 16 weeks

    Hemoglobin A1c recorded at initial and final visits

  8. Change in insulin resistance measure (HOMA-IR) from baseline

    Time frame: Baseline, 16 weeks

    HOMA-IR measured at initial and final visits

  9. Change in inflammatory marker (hsCRP) from baseline

    Time frame: Baseline, 16 weeks

    hsCRP measured at initial and final visits

  10. Change in lipid profile TG (triglycerides) from baseline

    Time frame: Baseline, 16 weeks

    Lipid profile TG measured at initial and final visits

  11. Change in lipid profile small LDL (small dense LDL) from baseline

    Time frame: Baseline, 16 weeks

    Lipid profile small LDL measured at initial and final visits

  12. Change in lipid profile (HDL) from baseline

    Time frame: Baseline,16 weeks

    Lipid profile HDL measured at initial and final visits

Secondary outcomes

  1. Psychiatric Indices - Mood

    Time frame: Baseline, 16 weeks

    Change in Mood Qualitative Score (Clinical Mood Monitoring) from baseline

  2. Psychiatric Indices- Clinical Global Impression

    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)

  3. Generalized Anxiety Disorder - GAD-7 Anxiety

    Time frame: Baseline, 16 weeks

    Change in Generalized Anxiety Symptom (GAD-7) scale from baseline. 0-15+ scale. (0= no anxiety, 15+= severe anxiety)

  4. Patient Health Questionnaire - PHQ-9 Depression

    Time frame: Baseline, 16 weeks

    Change in Patient Health Questionnaire (PHQ-9) from baseline. Score range 0-27 (0= no depression, 27= severe depression)

  5. Psychiatric Indices- Global Assessment of Functioning

    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)

  6. Psychiatric Indices- Quality of Life

    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)

  7. Psychiatric Indices- BPRS

    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)

  8. Pittsburgh Sleep Quality Index - PSQI

    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)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 2, 2019
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.