Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:54 PM
Study NCT ID:
NCT00858767
Status:
COMPLETED
Last Update Posted:
2010-12-16
First Post:
2009-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arabic Gum-Absorption Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-15', 'studyFirstSubmitDate': '2009-03-09', 'studyFirstSubmitQcDate': '2009-03-09', 'lastUpdatePostDateStruct': {'date': '2010-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum level menaquinone-7', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'plasma level of biochemical markers carboxylated matrix-Gla protein, undercarboxylated matrix-Gla protein, carboxylated osteocalcin, undercarboxylated osteocalcin', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vitamin K2', 'absorption', 'efficacy'], 'conditions': ['Bioavailability']}, 'descriptionModule': {'briefSummary': "Previous studies have indicated that menaquinone-7 (MK-7) is the most effective form of vitamin K. The Japanese soya product natto is one of the richest food sources of MK-7, but its taste is not appreciated by the Western society. For this reason, the active biological compound has been manufactured as enriched oil or casein (≈80% of proteins in cow's milk)-enriched powder. However, cow's milk allergy is the most common cause of food allergy affecting a minimum of 2-3% of infants. The investigators will therefore compare this protein-delivery system to an alternative delivery system (Arabic gum; 98% polysaccharides). To compare the difference between powder and oil as MK-7 delivery vehicle, the investigators will also test the efficacy of enriched linseed oil."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women aged between 20 and 40 y\n* Normal body weight and height (BMI \\<30 kg/m2)\n* Stable body weight (weight gain or loss \\<3 kg in past 3 mo)\n* Caucasian race\n* Written consent to take part in the study\n* Low vitamin K status\n\nExclusion Criteria:\n\n* (A history of) metabolic or gastrointestinal diseases\n* Chronic degenerative and/or inflammatory diseases\n* Abuse of drugs and/or alcohol\n* Use of corticosteroids\n* Use of oral anticoagulants\n* (A history of) soy allergy\n* Use of vitamin K-containing multivitamins or vitamin K supplements\n* Anaemia\n* Blood donation or participation in another study within one month before the study'}, 'identificationModule': {'nctId': 'NCT00858767', 'briefTitle': 'Arabic Gum-Absorption Study', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Comparison of Absorption and Efficacy of 3 Different Menaquinone-7 Delivery Systems; Casein Powder, Arabic Gum Powder, or Linseed Oil', 'orgStudyIdInfo': {'id': '08-3-064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '2 casein capsules per day existing of 90 µg menaquinone-7 per day for 8 weeks', 'interventionNames': ['Dietary Supplement: menaquinone-7 from casein capsules']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '2 arabic gum capsules per day existing of 90 µg menaquinone-7 per day for 8 weeks', 'interventionNames': ['Dietary Supplement: menaquinone-7 from arabic gum capsules']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': '2 linseed capsules existing of 90 µg menaquinone-7 per day for 8 weeks', 'interventionNames': ['Dietary Supplement: menaquinone-7 from linseed oil capsules']}], 'interventions': [{'name': 'menaquinone-7 from casein capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': '90 µg menaquinone-7 daily during 8 weeks', 'armGroupLabels': ['1']}, {'name': 'menaquinone-7 from arabic gum capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': '90 µg menaquinone-7 daily during 8 weeks', 'armGroupLabels': ['2']}, {'name': 'menaquinone-7 from linseed oil capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': '90 µg menaquinone-7 daily during 8 weeks', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PO Box 616', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'VitaK BV /University of Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Cees Vermeer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VitaK /University of Maastricht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. C. Vermeer', 'oldOrganization': 'VitaK BV'}}}}