Kidney InsufficiencyNYPRONCT04058951
Plant Versus Animal Dietary Protein and the Effect on Proteinuria
A study testing High Animal Protein Diet (HAPD) and High Plant Protein Diet (HPPD) in people with Kidney Insufficiency and Diabetes Mellitus, run by Jens Rikardt Andersen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Kidney Insufficiency, Diabetes Mellitus, Diabetes Mellitus, Type 2
- What is being tested?
- High Animal Protein Diet (HAPD) and High Plant Protein Diet (HPPD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2019to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Vegetarianism or veganism
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Hilleroed Hospital
Hillerød, 3400
Peter L Kristensen, Dr.med, 40845013, Peter.Lommer.Kristensen.01@regionh.dk
About this study
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
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.
Read the 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
- Being tested
- High Animal Protein Diet (HAPD), High Plant Protein Diet (HPPD)
- Medical subject headings
- Renal Insufficiency, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes Complications, Hypertension, Glomerulonephritis, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Animal Protein Diet (HAPD)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)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.
| Study group | Role | What they receive |
|---|---|---|
| High Animal Protein Diet (HAPD) | Placebo comparator | Consuming a diet high in protein primarily from animal origin. Receives: Other: High Animal Protein Diet (HAPD) |
| High Plant Protein Diet (HPPD) | Experimental | Consuming a diet high in protein exclusive from plant origin. Receives: Other: High Plant Protein Diet (HPPD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine albumin creatinine ratio (UACR)
The change in UACR (assessed by 2 days 24-hour urinal collection) between the two treatment arms
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start15 Aug 2019
- Primary completionMar 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jens Rikardt Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia, Inc., Nordsjaellands Hospital
- Responsible party
- Sponsor-investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Peter L Kristensen, Dr.med, Principal investigator, Hilleroed Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058951
- Sponsor's protocol ID
- NYPRO
- Acronym
- NYPRO
- Status last verified
- Sep 2019
- First submitted
- 14 Aug 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04058951
- Acronym / sponsor ID
- NYPRO / NYPRO
- Conditions
- Kidney Insufficiency, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes Complications, Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jens Rikardt AndersenUniversity, hospital or other
- Collaborators
- Nutricia, Inc., Nordsjaellands Hospital
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Animal Protein Diet (HAPD) | Placebo comparator | Other: High Animal Protein Diet (HAPD)Consuming a diet high in protein primarily from animal origin. |
| High Plant Protein Diet (HPPD) | Experimental | Other: High Plant Protein Diet (HPPD)Consuming a diet high in protein exclusive from plant origin. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Vegetarianism or veganism
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | High Animal Protein Diet (HAPD) |
| 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. | Other | High Plant Protein Diet (HPPD) |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter L Kristensen, Dr.med principal investigator
Hilleroed Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Animal Protein Diet (HAPD) and High Plant Protein Diet (HPPD) in people with Kidney Insufficiency and Diabetes Mellitus, run by Jens Rikardt Andersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens Rikardt Andersen, Lector (23346654, jra@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine albumin creatinine ratio (UACR) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.