Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT04058951
Status:
UNKNOWN
Last Update Posted:
2019-09-20
First Post:
2019-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Plant Versus Animal Dietary Protein and the Effect on Proteinuria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-18', 'studyFirstSubmitDate': '2019-08-14', 'studyFirstSubmitQcDate': '2019-08-15', 'lastUpdatePostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine albumin creatinine ratio (UACR)', 'timeFrame': '14 days', 'description': 'The change in UACR (assessed by 2 days 24-hour urinal collection) between the two treatment arms'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Insufficiency', 'Diabetes Mellitus', 'Diabetes Mellitus, Type 2', 'Diabetes Mellitus, Type 1', 'Diabetes Complications', 'Hypertension', 'Glomerulonephritis', 'Kidney Diseases', 'Kidney Disease, Chronic']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nKidney insufficiency is associated with increased morbidity and mortality, decreased quality of life and large financial costs for the health care system.\n\nEvidence 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.\n\nThe 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.\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* UACR between 30 and 800 mg/g in minimum two spot urine samples.\n* 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.\n* Minimum 30 years of age.\n* Danish speaking and writing\n* No changes in blood pressure medication for the past three months.\n\nExclusion Criteria:\n\n* Vegetarianism or veganism\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04058951', 'acronym': 'NYPRO', 'briefTitle': 'Plant Versus Animal Dietary Protein and the Effect on Proteinuria', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Dietary Protein Quality and Quantity: Effects of a High Protein Plant-based Diet on Proteinuria Among Patients With Nephropathy - A Randomized Cross-over Trial', 'orgStudyIdInfo': {'id': 'NYPRO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'High Animal Protein Diet (HAPD)', 'description': 'Consuming a diet high in protein primarily from animal origin.', 'interventionNames': ['Other: High Animal Protein Diet (HAPD)']}, {'type': 'EXPERIMENTAL', 'label': 'High Plant Protein Diet (HPPD)', 'description': 'Consuming a diet high in protein exclusive from plant origin.', 'interventionNames': ['Other: High Plant Protein Diet (HPPD)']}], 'interventions': [{'name': 'High Animal Protein Diet (HAPD)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['High Animal Protein Diet (HAPD)']}, {'name': 'High Plant Protein Diet (HPPD)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['High Plant Protein Diet (HPPD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Hillerød', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Peter L Kristensen, Dr.med', 'role': 'CONTACT', 'email': 'Peter.Lommer.Kristensen.01@regionh.dk', 'phone': '40845013'}], 'facility': 'Hilleroed Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}], 'centralContacts': [{'name': 'Jens Rikardt Andersen, Lector', 'role': 'CONTACT', 'email': 'jra@nexs.ku.dk', 'phone': '23346654'}], 'overallOfficials': [{'name': 'Peter L Kristensen, Dr.med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hilleroed Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jens Rikardt Andersen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nutricia, Inc.', 'class': 'INDUSTRY'}, {'name': 'Nordsjaellands Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jens Rikardt Andersen', 'investigatorAffiliation': 'University of Copenhagen'}}}}