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Completed

NCT Number: NCT02467530

Food Preparation Effects on Gut Bacteria in Patients on Peritoneal Dialysis

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

age

Other

Other names: Advanced Glycation End products

Primary outcomes

  1. Skin AGE level

    Time frame: baseline and 1 month

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

Secondary outcomes

  1. Serum AGE level

    Time frame: baseline and 1 month

    Change in serum AGE level at 1 month compared to baseline

  2. Serum IL-2 level

    Time frame: baseline and 1 month

    Change in serum IL-2 level at 1 month compared to baseline

  3. Serum CRP

    Time frame: baseline and 1 month

    Change in serum CRP level at 1 month compared to baseline

  4. Serum IL-10

    Time frame: baseline and 1 month

    Change in serum IL-10 level at 1 month compared to baseline

  5. Serum creatinine level

    Time frame: baseline and 1 month

    Change in serum creatinine level at 1 month compared to baseline

  6. Serum blood urea nitrogen (BUN)

    Time frame: baseline and 1 month

    Change in serum BUN at 1 month compared to baseline

  7. Serum p-cresol level

    Time frame: baseline and 1 month

    Change in serum p-cresol level at 1 month compared to baseline

  8. Serum indoxyl sulfate

    Time frame: baseline and 1 month

    Change in serum indoxyl sulfate level at 1 month compared to baseline

  9. Serum vitamin D

    Time frame: baseline and 1 month

    Change in serum vitamin D level at 1 month compared to baseline

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Effect of a Low AGE Diet on Human Microbiome

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 10, 2015
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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