Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-06 @ 12:45 AM
Study NCT ID:
NCT03019393
Status:
UNKNOWN
Last Update Posted:
2017-01-12
First Post:
2017-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Red Meat Intake on Occurrence of Serum Non-transferrin Bound Iron (NTBI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069466', 'term': 'Red Meat'}], 'ancestors': [{'id': 'D008460', 'term': 'Meat'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-01-11', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of serum non-transferrin bound iron (NTBI) after consumption of red meat', 'timeFrame': '2 hour post meal administration', 'description': 'Blood samples collected 2 h after consumption of red meat will be analyzed for non-transferrin bound iron (NTBI) concentration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['non-transferrin bound iron (NTBI)', 'Red meat', 'Non-transferrin bound iron (NTBI) in serum'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '11269606', 'type': 'BACKGROUND', 'citation': 'Trumbo P, Yates AA, Schlicker S, Poos M. Dietary reference intakes: vitamin A, vitamin K, arsenic, boron, chromium, copper, iodine, iron, manganese, molybdenum, nickel, silicon, vanadium, and zinc. J Am Diet Assoc. 2001 Mar;101(3):294-301. doi: 10.1016/S0002-8223(01)00078-5. No abstract available.'}, {'pmid': '619599', 'type': 'BACKGROUND', 'citation': 'Monsen ER, Hallberg L, Layrisse M, Hegsted DM, Cook JD, Mertz W, Finch CA. Estimation of available dietary iron. Am J Clin Nutr. 1978 Jan;31(1):134-41. doi: 10.1093/ajcn/31.1.134.'}, {'pmid': '15629195', 'type': 'BACKGROUND', 'citation': 'Papanikolaou G, Pantopoulos K. Iron metabolism and toxicity. Toxicol Appl Pharmacol. 2005 Jan 15;202(2):199-211. doi: 10.1016/j.taap.2004.06.021.'}, {'pmid': '15530152', 'type': 'BACKGROUND', 'citation': 'Hutchinson C, Al-Ashgar W, Liu DY, Hider RC, Powell JJ, Geissler CA. Oral ferrous sulphate leads to a marked increase in pro-oxidant nontransferrin-bound iron. Eur J Clin Invest. 2004 Nov;34(11):782-4. doi: 10.1111/j.1365-2362.2004.01416.x. No abstract available.'}, {'pmid': '22398912', 'type': 'BACKGROUND', 'citation': 'Schumann K, Kroll S, Romero-Abal ME, Georgiou NA, Marx JJ, Weiss G, Solomons NW. Impact of oral iron challenges on circulating non-transferrin-bound iron in healthy Guatemalan males. Ann Nutr Metab. 2012;60(2):98-107. doi: 10.1159/000336177. Epub 2012 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of red meat intake on occurrence of non-transferrin bound iron (NTBI)', 'detailedDescription': 'During Visit 1, blood samples will be collected to assess iron status. During Visit 2, after an overnight fast, participant will be given a standardized meal (rice and potatoes) with a portion of cooked beef (200 g). Blood samples will be collected right before and 2 hour after the meal for NTBI analysis.\n\nNTBI concentration before and after meal consumption will be compared.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Apparently healthy male volunteers (21 - 45 years old)\n* C-reactive protein (CRP) \\< 5 mg/L\n\nExclusion Criteria:\n\n* Blood donation or significant blood loss (e.g. surgery) within the past 4 months\n* Regular intake of iron and other nutrient supplements within the past 4 months\n* Regular intake of medication except oral contraceptives\n* Acute or recent inflammatory or infectious symptoms\n* Chronic gastrointestinal disorders or metabolic diseases\n* Smoking\n* Coeliac disease or gluten-related disorders\n* Iron deficiency anemia (Hb \\< 14 g/dL for males) with serum ferritin concentration \\< 30 ng/mL)\n* Non-iron deficiency anemia (serum ferritin concentration within normal range (30 - 300 ng/mL for males) but low hemoglobin (\\< 14 g/dL for males)\n* Iron overload conditions (serum ferritin concentration \\> 300 ng/mL for males)\n* Known hereditary disorders of iron metabolism'}, 'identificationModule': {'nctId': 'NCT03019393', 'briefTitle': 'Effect of Red Meat Intake on Occurrence of Serum Non-transferrin Bound Iron (NTBI)', 'organization': {'class': 'OTHER', 'fullName': 'National University of Singapore'}, 'officialTitle': 'Effect of Red Meat Intake on Occurrence of Serum Non-transferrin Bound Iron (NTBI)', 'orgStudyIdInfo': {'id': '13-441'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Beef', 'description': 'Beef topside fully cooked, 200g', 'interventionNames': ['Other: Beef']}], 'interventions': [{'name': 'Beef', 'type': 'OTHER', 'description': '200 g beef topside which is fully cooked will be provided to participant after overnight fast. The intervention is one time only.', 'armGroupLabels': ['Beef']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University of Singapore; National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Thomas Walczyk, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Walczyk', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Thomas Walczyk', 'investigatorAffiliation': 'National University of Singapore'}}}}