Hypertension Clinical Trial
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
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.
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.
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