Food Preparation Effects on Gut Bacteria in Patients on Peritoneal Dialysis

Mount Sinai Health System

Status: Completed

Conditions: End Stage Renal Disease (ESRD)

Treatments: Other: AGE

Study type: Interventional

Funder types: Other

Identifiers

NCT02467530

GCO 14-1961

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

AGE diet

Experimental group

Description:

Dietary intervention consistent of consuming low amounts of (AGEs).

Treatment:

Other: AGE

Original diet

No Intervention group

Description:

Patients will continue their original diet.