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

Background: 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.Methods: 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.Results: 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.Conclusion: 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.Dataset description: 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.Column descriptions: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).age: Age of the participant (years).male: Participant sex (1 = male, 0 = female).bmi: Body Mass Index (kg/m²).d_ala: Plasma D-alanine level (nmol/mL).d_ser: Plasma D-serine level (nmol/mL).indole: Fecal indole level (μg/g).p_cresol: Fecal p-cresol level (μg/g).