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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
75
Participants will consume 9.25g stick packs of the keto-like supplement dissolved in water 3 times per day for 8 weeks.
Participants will consume 9.25g stick packs of placebo dissolved in water 3 times per day for 8 weeks.
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States
RECRUITINGBOLD response during Monetary Incentive Delay Task
P5vP0 contrast in the nucleus accumbens during the Monetary Incentive Delay Task
Time frame: week 0 pre, week 0 post, week 8
BOLD response during Adjective Task
SELFvWORD contrast in the medial prefrontal cortex during the Adjective task
Time frame: week 0 pre, week 0 post, week 8
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