NCT06105762Not yet recruiting
Ketogenic Diet for Depression
KETO-MOOD: Ketogenic Diet for Microbiome Optimization and Overcoming Depression
Source: ClinicalTrials.gov · Last updated 30 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Globally, it's estimated that around 300 million people are affected by depressive illness, and even with access to modern mental health care, long-term recovery is uncommon. Recently, there has been increasing interest in a promising intervention: the ketogenic diet. This diet restricts carbohydrate intake, promoting the breakdown of fats into circulating ketone bodies, which can act as an additional energy source for the brain, potentially reducing its reliance on glucose. While various sources of evidence suggest the potential benefits of the ketogenic diet for individuals with depression, robust clinical studies on its efficacy in depressed patients are lacking. Our goal is to conduct an eight-week, assessor-blinded, randomized controlled trial to investigate the therapeutic effects of a very low-carbohydrate, high-fat ketogenic diet compared to an active comparator diet in individuals with depression.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 23 Oct 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- University Psychiatric Clinics Basel
- Diseases
- Depression, Bipolar disorder
- NCT number
- NCT06105762
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Jan 2024 to the primary completion date, 1 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current electroconvulsive therapy (ECT)
- Concurrent ketamine therapy
- Contraindicated medical conditions; besides rare hereditary metabolic disorders (typically diagnosed in childhood), contraindications comprise acute pancreatitis, nephrolithiasis, advanced renal failure, advanced liver failure, advanced congestive heart failure, advanced pulmonary disease with respiratory failure, and concurrent use of SGLT2 inhibitors
Other illness
- Inability to follow the study procedures, e.g., because of a language barrier, neurological and interfering mental disorders, dementia
- Inability to follow the procedures of the study, e.g. due to language barrier, neurological and interfering mental disorders, high-grade dementia, etc.
- Type 1 diabetes
- Insulin-dependent type 2 diabetes
Other
- Anorexia nervosa
- BMI \<18.5 kg/m2
- Pregnancy or breast feeding
- Porphyria
Who the study is looking for
- Unequivocal diagnosis of major depressive disorder or bipolar depression according to ICD-10 and ICD-11 (as soon as approved in Switzerland) criteria
- Age ≥18 years
- The patient can give informed consent as documented by signature
- Interest in trying a dietary intervention
- Participants must refrain from using any non-prescribed psychotropic agents during the study period including alcohol and illicit drugs such as cannabis; long term pain medication, caffeine and nicotine are excluded from that rule
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.