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

NCT06263660 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-04-20

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Laureate Institute for Brain Research, Inc.

    lead OTHER

Principal Investigators

  • Martin Paulus, MD · Laureate Institute for Brain Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-09
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06263660 on ClinicalTrials.gov