Food Preparation Effects on Gut Bacteria in Patients on Peritoneal Dialysis

End Stage Renal Disease (ESRD) Clinical Trial

Official title:

Effect of a Low AGE Diet on Human Microbiome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467530
• Other study ID #: GCO 14-1961
• Status: Completed
• Phase: N/A
• First received: June 8, 2015
• Last updated: January 17, 2017
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease (ESRD)
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Other:
• AGE

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum AGE level	Change in serum AGE level at 1 month compared to baseline	baseline and 1 month
Secondary	Serum IL-2 level	Change in serum IL-2 level at 1 month compared to baseline	baseline and 1 month
Secondary	Serum CRP	Change in serum CRP level at 1 month compared to baseline	baseline and 1 month
Secondary	Serum IL-10	Change in serum IL-10 level at 1 month compared to baseline	baseline and 1 month
Secondary	Serum creatinine level	Change in serum creatinine level at 1 month compared to baseline	baseline and 1 month
Secondary	Serum blood urea nitrogen (BUN)	Change in serum BUN at 1 month compared to baseline	baseline and 1 month
Secondary	Serum p-cresol level	Change in serum p-cresol level at 1 month compared to baseline	baseline and 1 month
Secondary	Serum indoxyl sulfate	Change in serum indoxyl sulfate level at 1 month compared to baseline	baseline and 1 month
Secondary	Serum vitamin D	Change in serum vitamin D level at 1 month compared to baseline	baseline and 1 month