Plant Versus Animal Dietary Protein and the Effect on Proteinuria

NCT ID: NCT04058951

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-15
• Study Completion Date: 2020-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High Animal Protein Diet (HAPD)

Consuming a diet high in protein primarily from animal origin.

Group Type: PLACEBO_COMPARATOR

High Animal Protein Diet (HAPD)

Intervention Type: OTHER

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)

Consuming a diet high in protein exclusive from plant origin.

Group Type: EXPERIMENTAL

High Plant Protein Diet (HPPD)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nutricia, Inc.

INDUSTRY

Sponsor Role: collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role: collaborator

Jens Rikardt Andersen

OTHER

Sponsor Role: lead

Responsible Party

Jens Rikardt Andersen

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peter L Kristensen, Dr.med

Role: PRINCIPAL_INVESTIGATOR

Hilleroed Hospital

Locations

Hilleroed Hospital

Hillerød, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Jens Rikardt Andersen, Lector

Role: CONTACT

jra@nexs.ku.dk

23346654

Facility Contacts

Peter L Kristensen, Dr.med

Role: primary

Peter.Lommer.Kristensen.01@regionh.dk

40845013

Other Identifiers

NYPRO

Identifier Type: -

Identifier Source: org_study_id