NCT06263660

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

Exploratory Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Effect of a Keto-Like Supplement in Depressed Patients on Functional Brain Responses to Positive and Negative Stimuli

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Laureate Institute for Brain Research, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-01-09
• Primary completion: 2026-12-31
• Completion: 2027-12-01
• First posted: 2024-02-16
• Last updated: 2026-04-20

Locations

1 site across 1 country: United States