Clinical trial NCT04058951: Plant Versus Animal Dietary Protein and the Effect on Proteinuria
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
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Insufficiency
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Diabetes Complications
Hypertension
Glomerulonephritis
Kidney Diseases
Kidney Disease, Chronic
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Nutricia, Inc.
name: Nordsjaellands Hospital
First posted: 2019-08-16
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Urine albumin creatinine ratio (UACR)
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Hilleroed Hospital
Study officials:
affiliation: Hilleroed Hospital
name: Peter L Kristensen, Dr.med
role: PRINCIPAL_INVESTIGATOR
References: