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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGE diet | Experimental | Dietary intervention consistent of consuming low amounts of (AGEs). |
|
| Original diet | No Intervention | Patients will continue their original diet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGE | Other |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Uribarri, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| John C He, MD | Icahn School of Medicine at Mount Sinai | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D017127 | Glycation End Products, Advanced |
| ID | Term |
|---|---|
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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| 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |