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RECRUITING
NCT06263660
PHASE2

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

Sponsor: Laureate Institute for Brain Research, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2024-01-09

Completion Date

2026-01

Last Updated

2025-03-04

Healthy Volunteers

No

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.

Locations (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, United States