Hongler Katarzyna, Lounici Astrid, Maurer Erin, Lanz Ueli, Szathmari Orsolya, Reuter Yvonne, Nussbaum Sandra, Steinborn Ines, Haedrich Annika, Mölling Melina A, Wein Ulf, Bocek Iona, Hersberger Luca, Brühl Annette B, Lang Undine E, Liwinski Timur
University Psychiatric Clinics Basel, Clinic for Adults, University of Basel, Basel, Switzerland.
Institut für Psychologie, Humboldt Universität zu Berlin, Berlin, Germany.
Neuroimmunomodulation. 2025;32(1):36-48. doi: 10.1159/000542979. Epub 2024 Dec 19.
Major depressive disorder (MDD) significantly impacts millions worldwide, with limited success in achieving remission for many patients, leading to high disease burden and increased suicide risk. Psychotherapy and antidepressants, although effective, do not provide relief for all, prompting the search for alternative treatments. Ketogenic diets have demonstrated positive effects on brain health. Our study aims to investigate the efficacy of the ketogenic diet in alleviating MDD symptoms, filling a critical gap in psychiatric treatment options and offering a novel dietary approach with potential to mitigate disease burden and enhance mental well-being.
This phase 2 randomized controlled trial will evaluate the efficacy of a 10-week program of dietitian counseling and ketogenic meal provision versus an intervention with similar dietetic contact promoting a healthy, insulin-lowering, non-ketogenic diet. The primary outcome is the change in the Patient Health Questionnaire nine-item depression score. Secondary outcomes include cognitive and affective mindfulness, self-efficacy, sleep, cognitive function, work and social adjustment, and various immunological, metabolic, and microbiome markers at weeks 6 and 10.
This study addresses a critical gap in depression treatment by exploring the ketogenic diet's potential as a metabolic mood enhancing intervention. Given the global impact of depression and limitations of current therapies, this research is valuable for exploring previously underappreciated neuroprotective and metabolic mechanisms and clinical benefits.
重度抑郁症（MDD）对全球数百万人产生了重大影响，许多患者实现症状缓解的成功率有限，导致疾病负担沉重且自杀风险增加。心理治疗和抗抑郁药虽然有效，但并非对所有人都能带来缓解，这促使人们寻找替代治疗方法。生酮饮食已被证明对大脑健康有积极影响。我们的研究旨在调查生酮饮食在减轻MDD症状方面的疗效，填补精神科治疗选择中的关键空白，并提供一种新的饮食方法，有可能减轻疾病负担并改善心理健康。
这项2期随机对照试验将评估为期10周的营养师咨询和提供生酮餐计划的疗效，并与促进健康、降低胰岛素的非生酮饮食的类似饮食咨询干预措施进行比较。主要结局指标是患者健康问卷九项抑郁评分的变化。次要结局指标包括第6周和第10周时的认知和情感正念、自我效能感、睡眠、认知功能、工作和社会适应，以及各种免疫、代谢和微生物组标志物。
本研究通过探索生酮饮食作为一种改善代谢从而提升情绪的干预措施的潜力，填补了抑郁症治疗中的关键空白。鉴于抑郁症的全球影响以及当前疗法的局限性，这项研究对于探索此前未得到充分重视的神经保护和代谢机制以及临床益处具有重要价值。
