Minimal dataset for Effects of sake lees intake on fecal uremic toxins, plasma D-alanine, constipation, and gut microbiome in healthy adults: A single-arm clinical trial

<b>Background: </b>Sake lees consumption has the potential to reduce uremic toxins by influencing the gut microbiome. To lay the groundwork for a clinical trial targeting chronic kidney disease (CKD) patients, we conducted a pilot study to explore the relationship between sake lees intake and changes in fecal uremic toxin levels among individuals with constipation. D-alanine, a renoprotective component of sake lees, was also evaluated.<br><b>Methods:</b> This single-arm, before and after study lacked a control group. Participants met the diagnostic criteria for chronic constipation. They consumed 25 or 50 g of sake lees daily for 6 weeks. The primary endpoint was the change in fecal indole levels from baseline. Secondary endpoints included changes in plasma D-alanine, Constipation Scoring System (CSS) scores, and the composition of the fecal microbiome.<b>Results:</b> Eight participants, with a mean age of 46 years, completed the study. Percentage changes in fecal indole levels were +42%, +52%, and −6% at weeks 2, 4, and 6, respectively. Plasma D-alanine levels showed percentage changes of +39%, +24%, and +38% at the same time points. CSS scores improved from 9.2 to 6.8 by week 2 and remained stable after week 4. The proportion of the phylum Firmicutes in the gut microbiome increased slightly from 53% at baseline to 57% by week 6.<br><b>Conclusion:</b> Sake lees intake may reduce fecal uremic toxins, elevate plasma D-alanine levels, alleviate constipation, and modify the gut microbiome. However, future studies are needed to confirm these effects in patients with CKD.<b>Dataset description:</b> This dataset contains the minimal underlying data from a single-arm clinical trial investigating the effects of sake lees intake on uremic toxins, D-amino acids, and gut-related parameters in healthy adults. The study measured several biological markers before and after the intervention period, including plasma D-alanine and D-serine, as well as fecal levels of indole and p-cresol. Participant demographics such as age, sex, and BMI are also included.<br><b>Column descriptions:</b><br>group: Intervention group assignment (0 = participants who consumed 25g of sake lees per day; 1 = participants who consumed 50g of sake lees per day).week: Time point of data collection (0 = baseline, 2 = week 2, 4 = week 4, 6 = week 6).<br>age: Age of the participant (years).male: Participant sex (1 = male, 0 = female).<br>bmi: Body Mass Index (kg/m²).d_ala: Plasma D-alanine level (nmol/mL).<br>d_ser: Plasma D-serine level (nmol/mL).indole: Fecal indole level (μg/g).<br>p_cresol: Fecal p-cresol level (μg/g).

<b>研究背景：</b>清酒酒糟（sake lees）可通过调控肠道微生物组（gut microbiome）降低尿毒症毒素（uremic toxins）水平。为开展针对慢性肾脏病（CKD）患者的临床试验奠定基础，本研究开展一项先导试验，探索便秘人群摄入清酒酒糟与粪便尿毒症毒素水平变化之间的关联，并对清酒酒糟中的肾保护成分D-丙氨酸（D-alanine）进行了评估。<br><b>研究方法：</b>本研究为单臂自身前后对照试验，未设置对照组。受试者符合慢性便秘的诊断标准，每日摄入25g或50g清酒酒糟，干预周期为6周。主要终点为粪便吲哚水平较基线的变化；次要终点包括血浆D-丙氨酸水平、便秘评分系统（CSS，Constipation Scoring System）评分及粪便微生物组组成的变化。<br><b>研究结果：</b>共8名平均年龄为46岁的受试者完成本试验。在第2、4、6周时，粪便吲哚水平的变化率分别为+42%、+52%和-6%；血浆D-丙氨酸水平在相同时间点的变化率分别为+39%、+24%和+38%。便秘评分系统评分在第2周时从基线的9.2分改善至6.8分，并在第4周后维持稳定。肠道微生物组中厚壁菌门（Firmicutes）的占比较基线的53%略有上升，至第6周时达到57%。<br><b>研究结论：</b>摄入清酒酒糟或可降低粪便尿毒症毒素水平、升高血浆D-丙氨酸水平、缓解便秘并调控肠道微生物组结构。但未来仍需开展针对慢性肾脏病患者的研究以验证上述效应。<br><b>数据集说明：</b>本数据集包含一项单臂临床试验的核心原始数据，该试验旨在探究清酒酒糟摄入对健康成年人尿毒症毒素、D-氨基酸及肠道相关参数的影响。本研究在干预周期前后测定了多项生物学标志物，包括血浆D-丙氨酸与D-丝氨酸（D-serine），以及粪便中的吲哚与对甲酚（p-cresol）水平；同时纳入了受试者的人口统计学信息，如年龄、性别与体质量指数（BMI，Body Mass Index）。<br><b>字段说明：</b><br>group：干预组分组（0=每日摄入25g清酒酒糟的受试者；1=每日摄入50g清酒酒糟的受试者）。<br>week：数据采集时间点（0=基线，2=第2周，4=第4周，6=第6周）。<br>age：受试者年龄（单位：岁）。<br>male：受试者性别（1=男性，0=女性）。<br>bmi：体质量指数（kg/m²）。<br>d_ala：血浆D-丙氨酸水平（单位：nmol/mL）。<br>d_ser：血浆D-丝氨酸（D-serine）水平（单位：nmol/mL）。<br>indole：粪便吲哚水平（单位：μg/g）。<br>p_cresol：粪便对甲酚（p-cresol）水平（单位：μg/g）。