Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-01-01 @ 5:57 PM
Study NCT ID:
NCT01304992
Status:
COMPLETED
Last Update Posted:
2012-11-27
First Post:
2011-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cholesterol-lowering Effects of Lupin Protein
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-22', 'studyFirstSubmitDate': '2011-02-25', 'studyFirstSubmitQcDate': '2011-02-25', 'lastUpdatePostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cholesterol metabolism', 'timeFrame': 'After 0, 4, 8, 12, 16 and 20 weeks', 'description': 'Blood lipids (LDL cholesterol, total cholesterol, HDL cholesterol, triacylglyceroles)'}], 'secondaryOutcomes': [{'measure': 'Protein metabolism', 'timeFrame': 'After 0, 8, 12 and 20 weeks', 'description': 'Plasma: amino acids, total protein, albumin, urea, uric acid; Urine: total protein, ammonia, urea, uric acid; Proteomic-study'}, {'measure': 'Body composition (body status)', 'timeFrame': 'After 0, 8, 12 and 20 weeks', 'description': 'Bioelectrical impedance analysis, body weight, blood pressure'}, {'measure': 'High-sensitive CRP', 'timeFrame': 'After 0, 8, 12 and 20 weeks', 'description': 'As inflammation marker'}, {'measure': 'Fasting glucose', 'timeFrame': 'After 0, 8, 12 and 20 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dietary protein', 'Lupin protein', 'Cholesterol metabolism', 'Protein metabolism', 'Hypercholesterolemia', 'Protein-enriched drinks'], 'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '23902673', 'type': 'DERIVED', 'citation': 'Bahr M, Fechner A, Kramer J, Kiehntopf M, Jahreis G. Lupin protein positively affects plasma LDL cholesterol and LDL:HDL cholesterol ratio in hypercholesterolemic adults after four weeks of supplementation: a randomized, controlled crossover study. Nutr J. 2013 Aug 1;12:107. doi: 10.1186/1475-2891-12-107.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to determine the efficacy of lupin protein drinks (Lupinus angustifolius Boregine) in humans. Parameters concerning cardiovascular risk factors and the metabolism of proteins, lipids and cholesterol will be evaluated.', 'detailedDescription': 'Based on the preliminary finding that a daily dosage of 35 g lupin protein is capable to affect plasma lipids positively, the physiological effects of two different daily lupin protein dosages will be investigated in two separate study groups (group A: 25 g protein/day; group B: 40 g protein/day). Both study groups undergo double-blinded and controlled study conditions in a cross-over design.\n\nIn each of the two study groups 35 volunteers with hypercholesterolemia will be allocated to one of two randomization groups: After a 1-week run-in period (baseline), half of the 35 participants of each study group will consume drinks with lupin protein in the respective amount (25 g or 40 g protein/day) over a period of eight weeks, the other half will receive the analogue amount of milk protein as well incorporated in a drink serving as control. After a wash-out period of four weeks, the protein source will be crossed within the two study groups for a second intervention period of eight weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate hypercholesterolemia (total cholesterol \\>5,2 mmol/L)\n* Age: 18-80 years old\n\nExclusion Criteria:\n\n* Intake of lipid-lowering pharmaceuticals\n* Allergy against legumes or milk protein\n* Intolerance against milk\n* Pregnancy, lactation\n* Chronic bowel disease'}, 'identificationModule': {'nctId': 'NCT01304992', 'briefTitle': 'Cholesterol-lowering Effects of Lupin Protein', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'Effects of Lupin Protein on Lipid and Protein Metabolism in Moderate Hypercholesterolemic Subjects', 'orgStudyIdInfo': {'id': 'LSEP H48-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lupin Protein', 'description': 'Lupin protein (cultivar: Lupinus angustifolius Boregine; incorporated in a drink)', 'interventionNames': ['Dietary Supplement: Protein drink - low dosage', 'Dietary Supplement: Protein drink - high dosage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference protein', 'description': 'Reference Protein (75% sodium caseinate (EM7; DMV international) and 25% milk protein (Megglosat HP; Meggle), incorporated in a drink)', 'interventionNames': ['Dietary Supplement: Protein drink - low dosage', 'Dietary Supplement: Protein drink - high dosage']}, {'type': 'NO_INTERVENTION', 'label': 'Wash out', 'description': 'Wash out (four weeks without any intervention between interventional periods)'}], 'interventions': [{'name': 'Protein drink - low dosage', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The subjects will consume 500 mL of a protein drink containing 25 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.', 'armGroupLabels': ['Lupin Protein', 'Reference protein']}, {'name': 'Protein drink - high dosage', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The subjects will consume 500 mL of a protein drink containing 40 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.', 'armGroupLabels': ['Lupin Protein', 'Reference protein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07743', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Friedrich Schiller University Jena, Department of Nutritional Physiology', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Gerhard Jahreis, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. habil.', 'investigatorFullName': 'Gerhard Jahreis', 'investigatorAffiliation': 'University of Jena'}}}}