KETO-MOOD: Ketogenic Diet for Microbiome Optimization and Overcoming Depression - A Protocol for a Randomized...

Area of Science:

• Psychiatry
• Nutritional Neuroscience
• Metabolic Psychiatry

Background:

• Major Depressive Disorder (MDD) affects millions globally, with many patients not achieving remission with current treatments.
• Limited efficacy of psychotherapy and antidepressants necessitates novel therapeutic strategies.
• Ketogenic diets show promise for brain health, suggesting potential in psychiatric applications.

Purpose of the Study:

• To evaluate the efficacy of a ketogenic diet intervention for alleviating MDD symptoms.
• To explore the ketogenic diet as a metabolic mood-enhancing treatment.
• To identify potential neuroprotective and clinical benefits of ketogenic diets in depression.

Main Methods:

• A 10-week phase 2 randomized controlled trial comparing a ketogenic diet with a healthy, insulin-lowering diet.
• Intervention includes dietitian counseling and ketogenic meal provision.
• Primary outcome: change in Patient Health Questionnaire (PHQ-9) depression score; secondary outcomes: mood, cognition, sleep, and biomarkers.

Main Results:

• Primary outcome: Change in PHQ-9 depression scores at 6 and 10 weeks.
• Secondary outcomes: Assessed changes in mindfulness, self-efficacy, sleep, cognitive function, social adjustment, and immunological, metabolic, and microbiome markers.
• Data analysis will determine the ketogenic diet's impact on depression and related factors.

Conclusions:

• This research addresses a critical gap in depression treatment options.
• The study explores the ketogenic diet's potential as a metabolic intervention for mood enhancement.
• Findings may offer valuable insights into novel dietary approaches for managing depression and improving mental health.