Impact of infrared moxibustion for patients with mild hyperlipidemia: a protocol for a randomized controlled trial

INTRODUCTION: Hyperlipidemia serves as a significant risk factor for cardiovascular diseases and cognitive impairment, making early intervention and management highly necessary. Infrared moxibustion, a modern complementary and alternative therapy, currently lacks high-quality clinical research to substantiate its efficacy and underlying mechanisms. Therefore, this study aims to evaluate the effects of infrared moxibustion on blood lipid levels in patients with hyperlipidemia, and to explore its potential mechanisms by analyzing changes in gut microbiota and their metabolites, as well as alterations in brain gray matter volume. PATIENT AND METHODS: This study will recruit 158 patients with mild hyperlipidemia and randomly assign them to either a genuine infrared moxibustion group or a sham infrared moxibustion group. The intervention will be administered twice weekly for a total of 8 weeks. Blood lipid levels, Montreal Cognitive Assessment scores, Hamilton Depression Rating Scale scores, Hamilton Anxiety Scale scores, and Pittsburgh Sleep Quality Index scores will be compared between the two groups before treatment, and at 4, 8, and 12 weeks post-treatment. Additionally, changes in gut microbiota, the gut microbiota metabolite trimethylamine N-oxide (TMAO), and brain gray matter volume will be detected and compared between the two groups before treatment and at 8 weeks post-treatment (See Graphic Abstract).