Design and rationale for an open-label, randomized, controlled pilot trial to evaluate the changes in blood uremic toxins in patients with chronic kidney disease by dietary therapy with sake lees

Toshiaki Tokumaru, Tadashi Toyama, Yusuke Nakade, Hisayuki Ogura, Megumi Oshima, Shiori Nakagawa, Motoe Furuichi, Shinji Kitajima, Norihiko Sakai, Miho Shimizu, Yasunori Iwata, Takashi Wada

Clinical and Experimental Nephrology(2024)

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摘要
Background Patients with chronic kidney disease (CKD) reportedly show dysbiosis, which is the imbalance of gut microbiome. Dysbiosis increases the uremic toxin level in the intestine, and uremic toxins transfer into the blood, causing CKD progression. Sake lees, a traditional Japanese fermented food, may help reduce uremic toxins by altering the gut microbiome. Additionally, D-alanine, which is present in sake lees, may have a renoprotective effect. The present pilot study aims to evaluate the effect of adding sake lees to the standard CKD dietary therapy in reducing blood uremic toxins. Methods This pilot study is a single-center, open-label, randomized controlled trial. Twenty-four patients with CKD will be enrolled and allocated 1:1 to the intervention and control groups. The intervention group will receive standard CKD dietary therapy with an additional intake of 50 g of sake lees per day for 8 weeks, whereas the control group will only receive standard CKD dietary therapy. The primary endpoint is the change in serum indoxyl sulfate after 8 weeks. The secondary endpoint is the plasma D-alanine and fecal microbiome changes. Conclusion This pilot study provides insight into the development of a new diet focused on gut microbiome and D-amino acids in patients with CKD. Clinical trial registration This protocol was approved by the Clinical Trial Review Board of Kanazawa University Hospital on October 27, 2022 (2022-001 [6139]) and available to the public on the website of the Japan Registry of Clinical Trials on November 22, 2022 (jRCT1040220095).
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关键词
Sake lees,Chronic kidney disease,Dysbiosis,Uremic toxins,D-amino acids
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