Plant Versus Animal Dietary Protein and the Effect on Proteinuria
NYPRO
Dietary Protein Quality and Quantity: Effects of a High Protein Plant-based Diet on Proteinuria Among Patients With Nephropathy - A Randomized Cross-over Trial
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2019
CompletedStudy Start
First participant enrolled
August 15, 2019
CompletedFirst Posted
Study publicly available on registry
August 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedSeptember 20, 2019
September 1, 2019
7 months
August 14, 2019
September 18, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Urine albumin creatinine ratio (UACR)
The change in UACR (assessed by 2 days 24-hour urinal collection) between the two treatment arms
14 days
Study Arms (2)
High Animal Protein Diet (HAPD)
PLACEBO COMPARATORConsuming a diet high in protein primarily from animal origin.
High Plant Protein Diet (HPPD)
EXPERIMENTALConsuming a diet high in protein exclusive from plant origin.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Vegetarianism or veganism
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jens Rikardt Andersenlead
- Nutricia, Inc.collaborator
- Nordsjaellands Hospitalcollaborator
Study Sites (1)
Hilleroed Hospital
Hillerød, 3400, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter L Kristensen, Dr.med
Hilleroed Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 14, 2019
First Posted
August 16, 2019
Study Start
August 15, 2019
Primary Completion
March 1, 2020
Study Completion
July 1, 2020
Last Updated
September 20, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share