Actively Recruiting
Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression
Led by Laureate Institute for Brain Research, Inc. · Updated on 2026-04-20
75
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to determine whether a keto-like supplement relative to placebo results in functional brain changes during fMRI tasks evaluating positive and negative valence in individuals with moderate to severe depression. In this double-blind randomized placebo-controlled trial, 75 individuals with a Patient Health Questionnaire (PHQ-9) scale score ≥ 10 (MDD) will be enrolled to participate in an 8-week treatment study to obtain 60 completers. Participants will be randomized with a 1-1 ratio to receive the keto-like supplement (n= 30 completers) or placebo (n=30 completers) taken orally three times per day for 8 weeks. Participants will undergo a 10.5-hour screening/baseline evaluation visit split over 2 days at week 0 including questionnaires, neuroimaging before and after supplement or placebo administration and blood draws, office visits at week 2 (1.5 hours), week 4 (3 hours), week 6 (0.5 hours), week 8 (6 hours), a follow-up visit at week 10 (1.5 hours) and two phone calls between visits (weeks 1 and 3) during which a brief clinical assessment will be obtained (10 minutes each). The total time involved in the study is approximately 23.5 hours.
CONDITIONS
Official Title
Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with major depressive disorder (MDD) without psychotic features according to DSM-5 criteria
- Patient Health Questionnaire (PHQ-9) score of 10 or higher
- C-Reactive Protein (CRP) value greater than 1
- Aged between 18 and 65 years
- Able to provide written informed consent
- Body Mass Index (BMI) between 19 and 38 kg/m2
- Medically stable based on lab tests, medical history, and vital signs
- No intention to become pregnant during the study
- Negative serum pregnancy test for women of childbearing potential at screening
- Consent to have any unexpected brain imaging findings reported
You will not qualify if you...
- Current or recent significant suicidality
- History of moderate or severe substance or alcohol use disorder within 12 months, except nicotine or caffeine
- Positive test for alcohol or drugs of abuse
- Current diagnosis of psychotic disorder, eating disorder, learning disability, or personality disorder interfering with study adherence
- Medication dose changes within 6 weeks before the study or plans to change dose during the study
- Plans to take vitamin or mineral supplements during the study
- Inability to complete MRI scans
- Pregnant or breastfeeding women
- Plans to conceive during the study or within 3 months after last dose
- Participation in other investigational drug/vaccine/device studies recently or currently
- Major surgery within 12 weeks before screening or planned during study participation
- Intake of omega-3 fatty acids (DHA, EPA, fish oil supplements)
- Significant cognitive impairment or clinically relevant progressive disease affecting study course
- Known metabolic disorders such as fatty acid oxidation or ketolysis disorders, diabetes types 1 or 2
- Allergy to Stevia sweetener, malic acid, or orange flavoring
- Concern about ability to follow supplement protocol
- Currently practicing or planning to start ketogenic or paleo diet during study
- Weight change over 5 kg within one month before intervention
- Medical, psychiatric, or other conditions limiting ability to consent, adhere to protocol, or complete study
- Contraindications to MRI such as metallic implants, electronic devices, or claustrophobia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
Research Team
T
Teresa Victor, PhD
CONTACT
C
Colleen McCallum
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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