Plant Versus Animal Dietary Protein and the Effect on Proteinuria (NYPRO)
Primary Purpose
Kidney Insufficiency, Diabetes Mellitus, Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
High Animal Protein Diet (HAPD)
High Plant Protein Diet (HPPD)
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Insufficiency
Eligibility Criteria
Inclusion Criteria:
- UACR between 30 and 800 mg/g in minimum two spot urine samples.
- Estimated Glomerular Filtration Rate (eGFR) >30 ml/min. eGFR must have been stabil over the past 6 months defined by a maximal fluctuation in eGFR of 10 ml/min.
- Minimum 30 years of age.
- Danish speaking and writing
- No changes in blood pressure medication for the past three months.
Exclusion Criteria:
- Vegetarianism or veganism
- Pregnancy
Sites / Locations
- Hilleroed HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
High Animal Protein Diet (HAPD)
High Plant Protein Diet (HPPD)
Arm Description
Consuming a diet high in protein primarily from animal origin.
Consuming a diet high in protein exclusive from plant origin.
Outcomes
Primary Outcome Measures
Urine albumin creatinine ratio (UACR)
The change in UACR (assessed by 2 days 24-hour urinal collection) between the two treatment arms
Secondary Outcome Measures
Full Information
NCT ID
NCT04058951
First Posted
August 14, 2019
Last Updated
September 18, 2019
Sponsor
Jens Rikardt Andersen
Collaborators
Nutricia, Inc., Nordsjaellands Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04058951
Brief Title
Plant Versus Animal Dietary Protein and the Effect on Proteinuria
Acronym
NYPRO
Official Title
Dietary Protein Quality and Quantity: Effects of a High Protein Plant-based Diet on Proteinuria Among Patients With Nephropathy - A Randomized Cross-over Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Rikardt Andersen
Collaborators
Nutricia, Inc., Nordsjaellands Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate if a diet high in plant protein improves kidney function in patients with kidney insufficiency and diabetes and/or hypertension and/or glomerulonephritis. The study is a non-blinded, randomized, controlled, cross-over-design with two intervention periods of each 14 days. Between the two interventions periods there is a washout period of 14 days. The participants are randomized to start with an individualized diet plan containing either high amounts of animal protein or high amounts of plant protein.
Detailed Description
The purpose of this study is to investigate if a diet high in protein (2,0 g/kg/d) of plant origin, decreases proteinuria amongst patients with diabetes, hypertension and/or glomerulonephritis with presence of micro- or mild macro albuminuria, compared to a diet high in protein of animal origin.
Kidney insufficiency is associated with increased morbidity and mortality, decreased quality of life and large financial costs for the health care system.
Evidence suggest that the source of protein may inflect the progression of the kidney disease where soy protein has shown a positive effect on estimated glomerular filtration rate and proteinuria amongst both diabetic and non-diabetic patients with nephropathy.
The study design is a 6-week, non-blinded cluster randomized, controlled, cross-over study with two intervention periods of each 14 days. Between interventions there is a washout period of 14 days. The participants are randomized to follow either a diet high in plant protein (HPPD) or a diet high in animal protein (HAPD). The diet plans are individualized to accommodate the participants energy requirements. Given the high amount of protein in the diets they are supplemented with either soy protein powder or beef protein powder. To measure primary and secondary endpoint, the participants are instructed to collect two times 24-hour urine sample at the first baseline, after 14 days and after 42 days. Blood samples are collected at the first baseline, after 14 days, at the second baseline and after 42 days.
To gain enough statistical power a minimum of 16 participants should be included. To accommodate a drop-out rate of 25%, 20 participants should be enrolled.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Insufficiency, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes Complications, Hypertension, Glomerulonephritis, Kidney Diseases, Kidney Disease, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Animal Protein Diet (HAPD)
Arm Type
Placebo Comparator
Arm Description
Consuming a diet high in protein primarily from animal origin.
Arm Title
High Plant Protein Diet (HPPD)
Arm Type
Experimental
Arm Description
Consuming a diet high in protein exclusive from plant origin.
Intervention Type
Other
Intervention Name(s)
High Animal Protein Diet (HAPD)
Intervention Description
A diet containing 2,0 g protein per kilo body weight per day from primarily animal origin. To accommodate the high protein intake, the diet is supplemented with protein powder based on beef isolate.
Intervention Type
Other
Intervention Name(s)
High Plant Protein Diet (HPPD)
Intervention Description
A diet containing 2,0 g protein per kilo body weight per day exclusively from plant origin. To accommodate the high protein intake, the diet is supplemented with protein powder based on soy isolate.
Primary Outcome Measure Information:
Title
Urine albumin creatinine ratio (UACR)
Description
The change in UACR (assessed by 2 days 24-hour urinal collection) between the two treatment arms
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
UACR between 30 and 800 mg/g in minimum two spot urine samples.
Estimated Glomerular Filtration Rate (eGFR) >30 ml/min. eGFR must have been stabil over the past 6 months defined by a maximal fluctuation in eGFR of 10 ml/min.
Minimum 30 years of age.
Danish speaking and writing
No changes in blood pressure medication for the past three months.
Exclusion Criteria:
Vegetarianism or veganism
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Rikardt Andersen, Lector
Phone
23346654
Email
jra@nexs.ku.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter L Kristensen, Dr.med
Organizational Affiliation
Hilleroed Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hilleroed Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter L Kristensen, Dr.med
Phone
40845013
Email
Peter.Lommer.Kristensen.01@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
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Plant Versus Animal Dietary Protein and the Effect on Proteinuria
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