End Stage Renal Disease (ESRD)NCT02467530
Food Preparation Effects on Gut Bacteria in Patients on Peritoneal Dialysis
A study testing AGE in people with End Stage Renal Disease (ESRD), run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease (ESRD)
- What is being tested?
- AGE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Effect of a Low AGE Diet on Human Microbiome
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.
Read the 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.
- Conditions
- End Stage Renal Disease (ESRD)
- Being tested
- AGE
- Keywords
- end stage renal disease, peritoneal dialysis (PD), advanced glycation end products, Gut Microbiota Inflammation
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGEOther
Also called Advanced Glycation End products
| Study group | Role | What they receive |
|---|---|---|
| AGE diet | Experimental | Dietary intervention consistent of consuming low amounts of (AGEs). Receives: Other: AGE |
| Original diet | No intervention | Patients will continue their original diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin AGE level
Change in AGE levels in the skin at 1 month compared to baseline will be measure using an AGE reader.
Measured: baseline and 1 month
Secondary outcomes (9)
Serum AGE level
Change in serum AGE level at 1 month compared to baseline
Measured: baseline and 1 month
Serum IL-2 level
Change in serum IL-2 level at 1 month compared to baseline
Measured: baseline and 1 month
Serum CRP
Change in serum CRP level at 1 month compared to baseline
Measured: baseline and 1 month
Serum IL-10
Change in serum IL-10 level at 1 month compared to baseline
Measured: baseline and 1 month
Serum creatinine level
Change in serum creatinine level at 1 month compared to baseline
Measured: baseline and 1 month
Serum blood urea nitrogen (BUN)
Change in serum BUN at 1 month compared to baseline
Measured: baseline and 1 month
Serum p-cresol level
Change in serum p-cresol level at 1 month compared to baseline
Measured: baseline and 1 month
Serum indoxyl sulfate
Change in serum indoxyl sulfate level at 1 month compared to baseline
Measured: baseline and 1 month
Serum vitamin D
Change in serum vitamin D level at 1 month compared to baseline
Measured: baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaime Uribarri, MD, Principal investigator, Icahn School of Medicine at Mount SinaiJohn C He, MD, Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467530
- Sponsor's protocol ID
- GCO 14-1961
- Status last verified
- Jan 2017
- First submitted
- 8 Jun 2015
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Low AGE Diet on Human Microbiome
- ClinicalTrials.gov ID
- NCT02467530
- Acronym / sponsor ID
- GCO 14-1961
- Conditions
- End Stage Renal Disease (ESRD)
- Keywords
- end stage renal disease, peritoneal dialysis (PD), advanced glycation end products, Gut Microbiota Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGE diet | Experimental | Other: AGEDietary intervention consistent of consuming low amounts of (AGEs). |
| Original diet | No intervention | –Patients will continue their original diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGEAlso: Advanced Glycation End products | Other | AGE diet |
Primary outcome
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.
9 secondary outcomes
Serum AGE level
Time frame: baseline and 1 month
Serum IL-2 level
Time frame: baseline and 1 month
Serum CRP
Time frame: baseline and 1 month
Serum IL-10
Time frame: baseline and 1 month
Serum creatinine level
Time frame: baseline and 1 month
Serum blood urea nitrogen (BUN)
Time frame: baseline and 1 month
Serum p-cresol level
Time frame: baseline and 1 month
Serum indoxyl sulfate
Time frame: baseline and 1 month
Serum vitamin D
Time frame: baseline and 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Uribarri, MD principal investigator
Icahn School of Medicine at Mount Sinai
John C He, MD study chair
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AGE in people with End Stage Renal Disease (ESRD), run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin AGE level (time frame: baseline and 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.