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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04058951
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
Nutricia, Inc.
Nordsjaellands Hospital
Information provided by (Responsible Party):
Jens Rikardt Andersen, University of Copenhagen

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Jens Rikardt Andersen, Lector 23346654 jra@nexs.ku.dk

Locations
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Denmark
Hilleroed Hospital Recruiting
Hillerød, Denmark, 3400
Contact: Peter L Kristensen, Dr.med    40845013    Peter.Lommer.Kristensen.01@regionh.dk   
Sponsors and Collaborators
Jens Rikardt Andersen
Nutricia, Inc.
Nordsjaellands Hospital
Investigators
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Principal Investigator: Peter L Kristensen, Dr.med Hilleroed Hospital
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Responsible Party: Jens Rikardt Andersen, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04058951    
Other Study ID Numbers: NYPRO
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Proteinuria
Glomerulonephritis
Renal Insufficiency
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Nephritis