Food Preparation Effects on Gut Bacteria in Patients on Peritoneal Dialysis

Effect of a Low AGE Diet on Human Microbiome

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease (ESRD)
• Intervention / Treatment: Other: AGE

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AGE diet; Dietary intervention consistent of consuming low amounts of (AGEs).	Other: AGE; Other Names: Advanced Glycation End products
No Intervention: Original diet; 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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Study Chair: John C He, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 8, 2015
• First Submitted That Met QC Criteria: June 9, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Estimate): January 19, 2017
• Last Update Submitted That Met QC Criteria: January 17, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: advanced glycation end products; end stage renal disease; peritoneal dialysis (PD); Gut Microbiota Inflammation
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: GCO 14-1961