Food Preparation Effects on Gut Bacteria in Patients on Peritoneal Dialysis
- Conditions
- End Stage Renal Disease (ESRD)
- Interventions
- Other: AGE
- Registration Number
- NCT02467530
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AGE diet AGE Dietary intervention consistent of consuming low amounts of (AGEs).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 CRP baseline and 1 month Change in serum CRP level 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 creatinine level baseline and 1 month Change in serum creatinine 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 p-cresol level baseline and 1 month Change in serum p-cresol 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
Trial Locations
- Locations (1)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States