Could a keto drink lift depression? new trial tests brain effects
NCT ID NCT06263660
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a keto-like supplement, taken as a drink three times daily for 8 weeks, changes brain activity in people with moderate to severe depression. Researchers will use brain scans to compare the supplement to a placebo in 75 adults. The goal is to see if the supplement affects how the brain responds to positive and negative experiences.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- keto-like supplement
- What this could lead to
- If it works, this could point toward a new dietary supplement to help ease depression symptoms by altering brain responses.
- What could go wrong
- This is an early phase 2 trial with only 75 people, so results may not apply widely. The supplement may show no benefit over placebo, and side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 75 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \[persons with metallic implants (e.g., intracranial metal clips) and carriers of electronic devices (e.g., pacemaker) or persons with claustrophobia\]
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Laureate Institute for Brain Research
RECRUITINGTulsa, Oklahoma, 74136, United States
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- Can a group program teach teens to cope before therapy starts?