Evaluating a keto-like supplement's effects on brain responses in depression

Exploratory Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Effect of a Keto-Like Supplement in Depressed Patients on Functional Brain Responses to Positive and Negative Stimuli

This study is testing whether a keto-like supplement can change brain activity and improve mood in people with moderate to severe depression.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Laureate Institute for Brain Research, Inc. (Academic / other)
• Locations: 1 site (Tulsa, Oklahoma)
• Trial ID: NCT06263660 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of a keto-like supplement on brain activity in response to emotional stimuli in individuals suffering from moderate to severe depression. It is a double-blind, randomized, placebo-controlled study involving 75 participants who will be assigned to receive either the supplement or a placebo for eight weeks. Participants will undergo various assessments, including fMRI scans and questionnaires, to evaluate changes in brain function and mood. The study aims to determine if the supplement can induce functional brain changes that correlate with emotional processing.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with moderate to severe depression, as indicated by a PHQ-9 score of 10 or higher.

Not a fit: Patients with a history of significant suicidality or substance use disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel dietary intervention for improving emotional responses in patients with depression.

How similar studies have performed: While there is ongoing research into dietary supplements for mental health, this specific approach using a keto-like supplement is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Meets the Diagnostic and statistical manual - 5 (DSM-5) diagnostic criteria for MDD without psychotic features (past or present), as confirmed by the M.I.N.I v7.0
* PHQ-9 score of ≥10
* C-Reactive Protein (CRP) value \> 1
* Age 18-65
* Consent ability and written consent
* Body Mass Index (BMI) between 19 and 38 kg/m2
* Medically stable based on clinical laboratory tests, medical history and vital signs
* No intention to become pregnant during the study
* A woman of childbearing potential must have a negative serum pregnancy test at screening
* Consent that possible random finding is reported (e.g. brain abnormality during imaging)

Exclusion Criteria:

* Has a current or recent history of clinically significant suicidality
* Has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 12 months before screening
* Has positive test result(s) for alcohol or drugs of abuse (including methadone, opiates, cocaine, cannabinoids, amphetamine/methamphetamine and ecstasy)
* Has a current diagnosis of a psychotic disorder (e.g. schizophrenia, bipolar disorder), an eating disorder (e.g. anorexia, bulimia), or learning disability or a personality disorder that is considered by the investigator to interfere with the ability of the subject to adhere to the protocol (e.g. narcissistic personality, borderline personality disorder)
* Change in medication dose and/or frequency within the last 6 weeks. Participants must be on stable medications for 6 weeks prior to enrollment.
* Plans to change medication dose/frequency during the course of the study. Must plan to remain on stable dose for the duration of the study, unless otherwise indicated by their provider during the course of the study.
* Plans to take vitamins and/or mineral supplements during the study. Must refrain for the duration of the study
* Unable to complete MRI scans
* Is a woman who is pregnant or breast feeding
* Plans to conceive a child while enrolled in this study or within 3 months after the last dose of the keto-like supplement
* Has received an investigational drug/vaccines, used an invasive investigational medical device within 60 days before the planned first dose of the keto-like supplement or has participated in 2 or more interventional clinical studies in the previous 1 year, or is currently enrolled in any drug or non-drug interventional study.
* Has had major surgery, (i.e. requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time they are expected to participate in the study.
* Intake of Omega 3 fatty acids (DHA, EPA, fish oil supplements)
* Significant cognitive impairment, clinically relevant or progressive disease (e.g., liver, kidney, cardiovascular system, respiratory tract, vascular system, brain, metabolism, thyroid) that could affect the course of the study
* Known metabolic disorders (e.g., fatty acid oxidation disorders, ketolysis/ketogenesis or glucogenesis disorder, hyperinsulinism (e.g., pancreatic neuroendocrine tumor), pyruvate carboxylase deficiency, Type 1 and Type 2 diabetes
* Allergy to Stevia sweetener, malic acid or orange flavoring
* Concern for inability to maintain adherence to the keto-like supplement administration protocol
* Currently practicing a ketogenic or paleo diet or planning to do so during the study period.
* Change in body weight of more than 5 kg within one month before the start of the intervention
* Medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study
* Contraindications to MRI examinations \[persons with metallic implants (e.g., intracranial metal clips) and carriers of electronic devices (e.g., pacemaker) or persons with claustrophobia\]

Where this trial is running

Tulsa, Oklahoma

• Laureate Institute for Brain Research — Tulsa, Oklahoma, United States (Recruiting)

Study contacts

• Principal investigator: Martin Paulus, MD — Laureate Institute for Brain Research
• Study coordinator: Teresa Victor, PhD

Conditions Depression