End Stage Renal Disease (ESRD)
Conditions
Keywords
end stage renal disease, peritoneal dialysis (PD), advanced glycation end products, Gut Microbiota Inflammation
Brief summary
This is an intervention study of the effects of food preparation on the gut bacteria in patients with end stage renal disease on peritoneal dialysis. This is a dietary intervention consistent of consuming low amounts of advanced glycation end products (AGEs), the products of protein and sugar interaction during food processing and preparation using high direct heat.
Detailed description
Gut microbes can influence numerous aspects of human biology. Alterations in the function and composition of gut microbial flora (gut microbiota) have been linked to different diseases such as obesity, diabetes and inflammation. Advanced Glycation End products (AGEs) are formed via the Maillard reaction, which consists of a complex network of non-enzymatic reactions involving the carbonyl groups of reducing sugars which react with the amino groups of proteins. AGEs are produced in vivo and being consumed. They have been implicated in increased risk of different diseases including atherosclerosis, CAD and kidney diseases. In this study, the investigators are evaluating the effects of consuming a low AGE diet in participants on peritoneal dialysis on the gut bacteria and inflammation.
Interventions
OTHERAGE
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years. * Patients with ESRD on PD. * Patients are able to understand and give consent. * Patients with estimated daily dietary AGE intake \> 12 AGE Eq/day (12,000 kiloUnits/day) based on 3-day food records.
Exclusion criteria
* Patient on antibiotics in the last three months. * Liver cirrhosis, and heart failure with EF \< 30%. * The use of chemotherapy, immunosuppressive medications, probiotics, and steroid in the last month. * Oral iron supplementation in the last month. * History of small or large intestine resection or small bowel obstruction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin AGE level | baseline and 1 month | Change in AGE levels in the skin at 1 month compared to baseline will be measure using an AGE reader. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum p-cresol level | baseline and 1 month | Change in serum p-cresol level at 1 month compared to baseline |
| Serum creatinine level | baseline and 1 month | Change in serum creatinine level at 1 month compared to baseline |
| Serum AGE level | baseline and 1 month | Change in serum AGE level at 1 month compared to baseline |
| Serum IL-2 level | baseline and 1 month | Change in serum IL-2 level at 1 month compared to baseline |
| Serum blood urea nitrogen (BUN) | baseline and 1 month | Change in serum BUN at 1 month compared to baseline |
| Serum IL-10 | baseline and 1 month | Change in serum IL-10 level at 1 month compared to baseline |
| Serum indoxyl sulfate | baseline and 1 month | Change in serum indoxyl sulfate level at 1 month compared to baseline |
| Serum vitamin D | baseline and 1 month | Change in serum vitamin D level at 1 month compared to baseline |
| Serum CRP | baseline and 1 month | Change in serum CRP level at 1 month compared to baseline |
Countries
United States
Outcome results
None listed