Plant Versus Animal Dietary Protein and the Effect on Proteinuria

Hypertension Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04058951
• Other study ID #: NYPRO
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: July 2020

Study information

• Verified date: September 2019
• Source: University of Copenhagen
• Contact: Jens Rikardt Andersen, Lector
• Phone: 23346654
• Email: jra[@]nexs.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Glomerulonephritis
• Hypertension
• Kidney Disease, Chronic
• Kidney Diseases
• Kidney Insufficiency
• Proteinuria
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Hilleroed Hospital	Hillerød

Sponsors (3)

Lead Sponsor	Collaborator
Jens Rikardt Andersen	Nordsjaellands Hospital, Nutricia, Inc.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine albumin creatinine ratio (UACR)	The change in UACR (assessed by 2 days 24-hour urinal collection) between the two treatment arms	14 days