Food Preparation Effects on Gut Bacteria in Patients on Peritoneal Dialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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End Stage Renal Disease (ESRD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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AGE diet

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

Group Type EXPERIMENTAL

AGE

Intervention Type OTHER

Original diet

Patients will continue their original diet.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AGE

Intervention Type OTHER

Other Intervention Names

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Advanced Glycation End products

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No