Plant Versus Animal Dietary Protein and the Effect on Proteinuria (NYPRO)

Jens Rikardt Andersen

Status: Unknown

Conditions: Diabetes Mellitus, Type 1; Hypertension; Glomerulonephritis; Diabetes Complications; Kidney Diseases; Kidney Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2; Kidney Disease, Chronic

Treatments: Other: High Animal Protein Diet (HAPD); Other: High Plant Protein Diet (HPPD)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04058951

NYPRO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups, including a placebo group

High Animal Protein Diet (HAPD)

Placebo Comparator group

Description:

Consuming a diet high in protein primarily from animal origin.

Treatment:

Other: High Animal Protein Diet (HAPD)

High Plant Protein Diet (HPPD)

Experimental group

Description:

Consuming a diet high in protein exclusive from plant origin.

Treatment:

Other: High Plant Protein Diet (HPPD)