Evaluation of a Keto-Like Supplement on Brain Responses to Emotional Stimuli in Depression

NCT ID: NCT06263660

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2026-01-31

Brief Summary

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

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Keto-like supplement

Participants will receive standardized 9.25g stick packs of the keto-like supplement. The study participants will take one of these stick packs dissolved in water three times a day (morning, noon, and evening) for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Keto-like supplement

Intervention Type: DIETARY_SUPPLEMENT

Participants will consume 9.25g stick packs of the keto-like supplement dissolved in water 3 times per day for 8 weeks.

Placebo

Participants will receive standardized 9.25g stick packs of placebo. The study participants will take one of these stick packs dissolved in water three times a day (morning, noon, and evening) for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Participants will consume 9.25g stick packs of placebo dissolved in water 3 times per day for 8 weeks.

Interventions

Keto-like supplement

Participants will consume 9.25g stick packs of the keto-like supplement dissolved in water 3 times per day for 8 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Participants will consume 9.25g stick packs of placebo dissolved in water 3 times per day for 8 weeks.

Intervention Type: DIETARY_SUPPLEMENT

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]

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laureate Institute for Brain Research, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Paulus, MD

Role: PRINCIPAL_INVESTIGATOR

Laureate Institute for Brain Research

Locations

Laureate Institute for Brain Research

Tulsa, Oklahoma, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Teresa Victor, PhD

Role: CONTACT

tvictor@laureateinstitute.org

918-502-5108

Colleen McCallum

Role: CONTACT

cmccallum@laureateinstitute.org

918-502-5180

Facility Contacts

Teresa Victor, PhD

Role: primary

tvictor@laureateinstitute.org

918-502-5108

Colleen McCallum

Role: backup

918-502-5180

Other Identifiers

2022-007

Identifier Type: -

Identifier Source: org_study_id