Testing a synbiotic functional drink to support kidney and metabolic health in adults with diabetic kidney disease

Approved 28/08/2026, Bioethics Committee of the Autonomous University of Aguascalientes (Universidad Autónoma de Aguascalientes, Av. Universidad #940, Ciudad Universitaria, C.P., Aguascalientes, 20100, Mexico; +52 (0)449 910 7400; aquinta@correo.uaa.mx), ref: COB-UAA/25/2026

1. HbA1c (%) measured using a turbidimetric immunoassay at baseline and week 10
2. Fasting blood glucose (mg/dL) measured using the standard glucose oxidase method, based on spectrophotometric detection of absorbance changes in an automated clinical chemistry analyzer with integrated software, at baseline, week 5, and week 10
3. Serum creatinine (mg/dL) measured using an enzymatic method with spectrophotometric colorimetric detection in an automated clinical chemistry analyzer with integrated software, at baseline, week 5, and week 10
4. Serum urea and blood urea nitrogen (BUN, mg/dL) measured using the urease-glutamate dehydrogenase enzymatic method, based on the ultraviolet absorbance decrease caused by NADH consumption, in an automated clinical chemistry analyzer with integrated software, at baseline, week 5, and week 10
5. Urinary albumin-to-creatinine ratio (ACR, mg/g) measured using a urine sample. Albumin is quantified using an immunoturbidimetric method, and urinary creatinine is measured enzymatically in an automated clinical chemistry analyzer with integrated software. The ACR is calculated by dividing urinary albumin concentration by urinary creatinine concentration and expressing the result as milligrams of albumin per gram of creatinine (mg/g). Measured at baseline and week 10

1. Complete blood count and erythrocyte indices (haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration and red cell distribution width) measured using flow cytometry at baseline and week 10
2. Absolute lymphocyte count and neutrophil-to-lymphocyte ratio measured using the complete blood count at baseline and week 10.
3. Functional gastrointestinal symptoms measured using a structured questionnaire based on Rome IV criteria at baseline and week 10.
4. Nutritional status and anthropometry, including body weight measured using a calibrated digital scale; BMI calculated from body weight and height; mid-upper arm circumference measured with a non-stretchable anthropometric tape; triceps skinfold measured using a skinfold caliper; and arm muscle area calculated from MUAC and triceps skinfold, at baseline and week 10.
5. Adherence and adverse events are measured as follows: adherence is assessed using structured questionnaires or interviews, along with protocol compliance verification to ensure that participants follow study instructions (diet, activity, measurements, and biochemical checks). Adverse events are monitored through interviews, physical examinations, laboratory evaluations, and vital signs throughout the 10-week intervention.
6. Exploratory faecal microbiome taxonomic diversity/abundance, if resources and collaboration with INMEGEN are available and separate consent is provided measured using microbiome sequencing at the end of the 10-week intervention.