NCT02467530

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

June 8, 2015

Last Update Submit

January 17, 2017

Conditions

End Stage Renal Disease (ESRD)

Keywords

end stage renal diseaseperitoneal dialysis (PD)advanced glycation end productsGut Microbiota Inflammation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Serum AGE level

    baseline and 1 month

  • Serum IL-2 level

    baseline and 1 month

  • Serum CRP

    baseline and 1 month

  • Serum IL-10

    baseline and 1 month

  • Serum creatinine level

    baseline and 1 month

  • +4 more secondary outcomes

Study Arms (2)

AGE diet

EXPERIMENTAL

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

Other: AGE

Original diet

NO INTERVENTION

Patients will continue their original diet.

Interventions

AGEOTHER
Also known as: Advanced Glycation End products
AGE diet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Glycation End Products, Advanced

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycoconjugatesCarbohydratesToxins, BiologicalBiological Factors

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 10, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 19, 2017

Record last verified: 2017-01

Locations

US(1)