NCT02360748

Brief Summary

The study proposes that addition of high protein plant based diet will improve serum albumin as well serum phosphate for patients with End Stage Renal Disease (ESRD) on Dialysis. Patient will be provided additional food items to help improve their nutritional status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

February 3, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2017

Completed
Last Updated

April 13, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

February 3, 2015

Last Update Submit

April 12, 2018

Conditions

End-Stage Renal DiseaseMalnutrition

Outcome Measures

Primary Outcomes (1)

  • Nutritional Parameters, bone and mineral metabolism

    albumin will improve on high protein plant based diet; we will measure patients' baseline nutritional parameters which will include serum album; Calcium and phosphate levels and then follow the same parameters on the dietary intervention

    one month

Secondary Outcomes (2)

  • Phosphorous measurements will be followed during the course of the study and on completion

    one month

  • Obesity

    one month

Study Arms (1)

single

EXPERIMENTAL

Pilot Study in which patients will be adding food items to improve their nutritional status

Dietary Supplement: Plant based high protein food items

Interventions

Plant based high protein food itemsDIETARY_SUPPLEMENT

Patients will add high protein plant based food items to their diet

single

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ESRD Patients on dialysis with an albumin of \<4.0 with the ability to consent and willingness to enroll in the study

You may not qualify if:

  • liver cirrhosis,
  • cardiac cirrhosis,
  • dysphagia due to an old Cerebrovascular accident / muscular dystrophy,
  • Hyperkalemia (\>5.5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

OCHSNER

Baton Rouge, Louisiana, 70809, United States

Location

Davita

Baton Rouge, Louisiana, 70810, United States

Location

Related Publications (3)

  • Kalantar-Zadeh K, Gutekunst L, Mehrotra R, Kovesdy CP, Bross R, Shinaberger CS, Noori N, Hirschberg R, Benner D, Nissenson AR, Kopple JD. Understanding sources of dietary phosphorus in the treatment of patients with chronic kidney disease. Clin J Am Soc Nephrol. 2010 Mar;5(3):519-30. doi: 10.2215/CJN.06080809. Epub 2010 Jan 21.

    PMID: 20093346BACKGROUND

  • Noori N, Sims JJ, Kopple JD, Shah A, Colman S, Shinaberger CS, Bross R, Mehrotra R, Kovesdy CP, Kalantar-Zadeh K. Organic and inorganic dietary phosphorus and its management in chronic kidney disease. Iran J Kidney Dis. 2010 Apr;4(2):89-100.

    PMID: 20404416BACKGROUND

  • Noori N, Kalantar-Zadeh K, Kovesdy CP, Bross R, Benner D, Kopple JD. Association of dietary phosphorus intake and phosphorus to protein ratio with mortality in hemodialysis patients. Clin J Am Soc Nephrol. 2010 Apr;5(4):683-92. doi: 10.2215/CJN.08601209. Epub 2010 Feb 25.

    PMID: 20185606RESULT

MeSH Terms

Conditions

Kidney Failure, ChronicMalnutrition

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 SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 11, 2015

Study Start

October 1, 2015

Primary Completion

September 15, 2017

Study Completion

September 15, 2017

Last Updated

April 13, 2018

Record last verified: 2018-04

Locations

US(2)