Food Preparation Effects on Gut Bacteria in Patients on Peritoneal Dialysis

Study Overview
=================
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.

Official Title
-----------------
Effect of a Low AGE Diet on Human Microbiome

Conditions
-----------------
End Stage Renal Disease (ESRD)

Intervention / Treatment
-----------------
* Other: AGE


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGE diet<br>Dietary intervention consistent of consuming low amounts of (AGEs). | Other: AGE<br> <br> * Other names: Advanced Glycation End products;|
| No Intervention: Original diet<br>Patients will continue their original diet. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin AGE level | Change in AGE levels in the skin at 1 month compared to baseline will be measure using an AGE reader. | baseline and 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum AGE level | Change in serum AGE level at 1 month compared to baseline | baseline and 1 month | 
| Serum IL-2 level | Change in serum IL-2 level at 1 month compared to baseline | baseline and 1 month | 
| Serum CRP | Change in serum CRP level at 1 month compared to baseline | baseline and 1 month | 
| Serum IL-10 | Change in serum IL-10 level at 1 month compared to baseline | baseline and 1 month | 
| Serum creatinine level | Change in serum creatinine level at 1 month compared to baseline | baseline and 1 month | 
| Serum blood urea nitrogen (BUN) | Change in serum BUN at 1 month compared to baseline | baseline and 1 month | 
| Serum p-cresol level | Change in serum p-cresol level at 1 month compared to baseline | baseline and 1 month | 
| Serum indoxyl sulfate | Change in serum indoxyl sulfate level at 1 month compared to baseline | baseline and 1 month | 
| Serum vitamin D | Change in serum vitamin D level at 1 month compared to baseline | baseline and 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
end stage renal disease, peritoneal dialysis (PD), advanced glycation end products, Gut Microbiota Inflammation