Clinical trial NCT02467530: Food Preparation Effects on Gut Bacteria in Patients on Peritoneal Dialysis
Official title: Effect of a Low AGE Diet on Human Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease (ESRD)
Keywords: end stage renal disease
peritoneal dialysis (PD)
advanced glycation end products
Gut Microbiota Inflammation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Skin AGE level
timeFrame: baseline and 1 month
Secondary outcomes:
measure: Serum AGE level
timeFrame: baseline and 1 month
measure: Serum IL-2 level
timeFrame: baseline and 1 month
measure: Serum CRP
timeFrame: baseline and 1 month
measure: Serum IL-10
timeFrame: baseline and 1 month
measure: Serum creatinine level
timeFrame: baseline and 1 month
measure: Serum blood urea nitrogen (BUN)
timeFrame: baseline and 1 month
measure: Serum p-cresol level
timeFrame: baseline and 1 month
measure: Serum indoxyl sulfate
timeFrame: baseline and 1 month
measure: Serum vitamin D
timeFrame: baseline and 1 month
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jaime Uribarri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: John C He, MD
role: STUDY_CHAIR
References: