Plant Versus Animal Dietary Protein and the Effect on Proteinuria (NYPRO)
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|ClinicalTrials.gov Identifier: NCT04058951|
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : September 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Kidney Insufficiency Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Diabetes Complications Hypertension Glomerulonephritis Kidney Diseases Kidney Disease, Chronic||Other: High Animal Protein Diet (HAPD) Other: High Plant Protein Diet (HPPD)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 15, 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||July 2020|
Placebo Comparator: High Animal Protein Diet (HAPD)
Consuming a diet high in protein primarily from animal origin.
Other: High Animal Protein Diet (HAPD)
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.
Experimental: High Plant Protein Diet (HPPD)
Consuming a diet high in protein exclusive from plant origin.
Other: High Plant Protein Diet (HPPD)
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.
- Urine albumin creatinine ratio (UACR) [ Time Frame: 14 days ]The change in UACR (assessed by 2 days 24-hour urinal collection) between the two treatment arms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058951
|Contact: Jens Rikardt Andersen, Lectoremail@example.com|
|Hillerød, Denmark, 3400|
|Contact: Peter L Kristensen, Dr.med 40845013 Peter.Lommer.Kristensen.firstname.lastname@example.org|
|Principal Investigator:||Peter L Kristensen, Dr.med||Hilleroed Hospital|