Keto-Like Supplement for Depression
This study is testing if a keto-like supplement can change how the brain responds to emotions in people with depression. Researchers want to see if this supplement, compared to a placebo (an inactive substance), affects brain activity measured by fMRI (functional magnetic resonance imaging) scans. You might be able to join if you are 18-65 years old, have moderate to severe depression (a PHQ-9 score of 10 or higher), and a C-Reactive Protein (CRP) level above 1. The study will involve 75 participants, and success will be measured by changes in brain responses during specific tasks.
- Study design
- This is a double-blind, randomized, placebo-controlled study, meaning neither you nor the researchers will know if you're receiving the keto-like supplement or the placebo. About 75 participants will be enrolled.
- What's involved
- You would take a keto-like supplement or placebo dissolved in water three times a day for 8 weeks. You will also have fMRI scans at the beginning, immediately after starting, and at the end of the 8 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Brain responses will be measured at week 0 (before and after starting the supplement) and at week 8.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06263660
Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression
Recruiting
PHASE2Ages 18–65InterventionalBasic scienceLaureate Institute for Brain Research, Inc.Investigator-initiated
~75 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:Keto-like supplementPlacebo
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
BOLD response during Monetary Incentive Delay Task
Measured over week 0 pre, week 0 post, week 8
Conditions
Where it's being run
1 sites across 1 statesOklahoma1
Study leadership
- Martin Paulus, MD · PRINCIPAL_INVESTIGATOR · Laureate Institute for Brain Research
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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 \[persons with metallic implants (e.g., intracranial metal clips) and carriers of electronic devices (e.g., pacemaker) or persons with claustrophobia\]
What this trial measures
- BOLD response during Monetary Incentive Delay Taskweek 0 pre, week 0 post, week 8
P5vP0 contrast in the nucleus accumbens during the Monetary Incentive Delay Task