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Food Preparation Effects on Gut Bacteria in Patients on Peritoneal Dialysis

Primary Purpose

End Stage Renal Disease (ESRD)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AGE
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End Stage Renal Disease (ESRD) focused on measuring end stage renal disease, peritoneal dialysis (PD), advanced glycation end products, Gut Microbiota Inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AGE diet

Original diet

Arm Description

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

Patients will continue their original diet.

Outcomes

Primary Outcome Measures

Skin AGE level
Change in AGE levels in the skin at 1 month compared to baseline will be measure using an AGE reader.

Secondary Outcome Measures

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

Full Information

First Posted
June 8, 2015
Last Updated
January 17, 2017
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT02467530
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease (ESRD)
Keywords
end stage renal disease, peritoneal dialysis (PD), advanced glycation end products, Gut Microbiota Inflammation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AGE diet
Arm Type
Experimental
Arm Description
Dietary intervention consistent of consuming low amounts of (AGEs).
Arm Title
Original diet
Arm Type
No Intervention
Arm Description
Patients will continue their original diet.
Intervention Type
Other
Intervention Name(s)
AGE
Other Intervention Name(s)
Advanced Glycation End products
Primary Outcome Measure Information:
Title
Skin AGE level
Description
Change in AGE levels in the skin at 1 month compared to baseline will be measure using an AGE reader.
Time Frame
baseline and 1 month
Secondary Outcome Measure Information:
Title
Serum AGE level
Description
Change in serum AGE level at 1 month compared to baseline
Time Frame
baseline and 1 month
Title
Serum IL-2 level
Description
Change in serum IL-2 level at 1 month compared to baseline
Time Frame
baseline and 1 month
Title
Serum CRP
Description
Change in serum CRP level at 1 month compared to baseline
Time Frame
baseline and 1 month
Title
Serum IL-10
Description
Change in serum IL-10 level at 1 month compared to baseline
Time Frame
baseline and 1 month
Title
Serum creatinine level
Description
Change in serum creatinine level at 1 month compared to baseline
Time Frame
baseline and 1 month
Title
Serum blood urea nitrogen (BUN)
Description
Change in serum BUN at 1 month compared to baseline
Time Frame
baseline and 1 month
Title
Serum p-cresol level
Description
Change in serum p-cresol level at 1 month compared to baseline
Time Frame
baseline and 1 month
Title
Serum indoxyl sulfate
Description
Change in serum indoxyl sulfate level at 1 month compared to baseline
Time Frame
baseline and 1 month
Title
Serum vitamin D
Description
Change in serum vitamin D level at 1 month compared to baseline
Time Frame
baseline and 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Uribarri, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John C He, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Study Chair
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Food Preparation Effects on Gut Bacteria in Patients on Peritoneal Dialysis

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