Trials / Unknown
UnknownNCT05705063
Impact of a Ketogenic Diet on Metabolic and Psychiatric Health in Patients With Bipolar Illness
Impact of A Low-Carbohydrate, High-Fat, Ketogenic Diet on Obesity, Metabolic Abnormalities, and Psychiatric Symptoms on Patients With Bipolar Disorder (BPD)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- 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 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 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
- Bipolar Disorder I
- Bipolar II Disorder
- Bipolar I Disorder
- Bipolar Disorder
- Bipolar Depression
- Bipolar and Related Disorders
- Bipolar Disorder, Type 1
- Bipolar Disorder, Type 2
- Bipolar Disorder, Mixed
- Obesity
- Metabolic Syndrome
- Ketogenic Dieting
- Weight Gain
- Brain Metabolic Disorder
- Psychotropic Agents Causing Adverse Effects in Therapeutic Use
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | LCHF Ketogenic Diet | Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 6 weeks |
Timeline
- Start date
- 2023-01-30
- Primary completion
- 2024-06-30
- Completion
- 2024-12-30
- First posted
- 2023-01-30
- Last updated
- 2023-01-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05705063. Inclusion in this directory is not an endorsement.