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

Conditions

• Depression

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Keto-like supplement — 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 — DIETARY_SUPPLEMENT
  Participants will consume 9.25g stick packs of placebo dissolved in water 3 times per day for 8 weeks.

Study Details

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.

Key Dates

Start date

Jan 9, 2024

Status verified

Apr 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

75 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Active Comparator: 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.
• Placebo Comparator: 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.

Primary Outcome Measure

BOLD response during Monetary Incentive Delay Task [ Time Frame: week 0 pre, week 0 post, week 8 ]

Central Contacts

• Teresa Victor, PhD
  918-502-5108
  [email protected]
• Colleen McCallum
  918-502-5180
  [email protected]

Locations (1)

Find similar trials in Tulsa, OK

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