Trials / Completed
CompletedNCT03935854
Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar or Schizophrenia Illness
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
- Obesity
- Ketogenic Dieting
- Metabolic Syndrome
- Bipolar Disorder
- Schizophrenia
- Weight Gain
- Psychotropic Agents Causing Adverse Effects in Therapeutic Use
- Brain Metabolic Disorder
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | LCHF, Ketogenic Diet | Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 16 weeks |
Timeline
- Start date
- 2019-02-13
- Primary completion
- 2022-08-11
- Completion
- 2022-08-11
- First posted
- 2019-05-02
- Last updated
- 2024-12-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03935854. Inclusion in this directory is not an endorsement.