Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-07 @ 11:09 AM
Study NCT ID:
NCT02423460
Status:
COMPLETED
Last Update Posted:
2018-11-06
First Post:
2015-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Threonine Requirement in IBD Adults and Healthy Adult Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013912', 'term': 'Threonine'}, {'id': 'D000596', 'term': 'Amino Acids'}], 'ancestors': [{'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-02', 'studyFirstSubmitDate': '2015-04-12', 'studyFirstSubmitQcDate': '2015-04-17', 'lastUpdatePostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Threonine requirement in those with Crohn's Disease, ulcerative colitis and in healthy controls determined using the indicator amino acid oxidation method", 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ulcerative Colitis', 'Healthy Controls', "Crohn's Disease"], 'conditions': ['Ulcerative Colitis', "Crohn's Disease", 'Healthy']}, 'descriptionModule': {'briefSummary': "The daily requirement of threonine, an essential amino acid, will be evaluated in healthy adult males and in adult males with Crohn's Disease or ulcerative colitis using the indicator amino acid oxidation (IAAO) method. Participants will consume specially formulated diets with varying levels of threonine.", 'detailedDescription': "Threonine is an essential amino acid which must be obtained from the diet. It is a component of mucin. Mucin, in turn, is a key protein in the mucous membrane that protects the lining of the intestine.\n\nInflammatory bowel disease (IBD) is a group of inflammatory conditions that affect the colon and small intestine. IBD primarily includes ulcerative colitis (UC) and Crohn's disease (CD). In UC, the inflammation is usually in the colon whereas in CD inflammation may occur anywhere along the digestive tract. Studies in animals have shown that more threonine is used when there is inflammation in the intestine.\n\nThe threonine requirement in healthy participants and in IBD patients will be determined using the indicator amino acid oxidation method. The requirement derived in healthy participants will be compared to that derived in patients with IBD.\n\nEach participant will take part in two x 3 day study periods. The first two days are called adaptation days where the subjects will consume a liquid diet specially designed for him. The diet will be consumed at home. It contains all vitamins, minerals, protein and all other nutrients required. On the third day, the participant will come to the Hospital for Sick Children in Toronto. Subjects will consume hourly meals for a total of 8 meals and a stable isotope 13C-phenylalanine. Breath and urine samples will be collected to measure the oxidation of phenylalanine from which the threonine requirement will be determined."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria (healthy controls):\n\n* Male age 18 - 40 years of age\n* Having obtained his (or his legal representative's) written informed consent.\n* Normally nourished and without any inter-current illness.\n* Absence of an active inflammatory process in the past month.\n\nExclusion Criteria (healthy controls):\n\n* Subject who cannot be expected to comply with the study procedures.\n* Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.\n\nInclusion Criteria: Crohn's Disease and Ulcerative Colitis\n\n* Male age 18 - 40 years of age\n* Having obtained his (or his legal representative's) Written Informed Consent.\n* For both conditions, stable disease state and not malnourished per the treating physician.\n* CD: Harvey Bradshaw Index (HBI) ≤ 8, disease location: evidence of ileal and or colon inflammatory involvement, no known strictures\n* UC: Mayo Score ≤ 7 (or Partial Mayo Score ≤5)\n* No tube feeding - Subjects must be treated and followed by the Gastroenterology team at Mt. Sinai Hospital, Toronto.\n\nExclusion Criteria: Crohn's Disease and Ulcerative Colitis\n\n* Uncontrolled inflammation which will likely require surgery or escalation of therapy in the next 4 weeks\n* Concomitant treatment:corticosteroids \\> 20mg/day\n* Subject who cannot be expected to comply with the study procedures. - Subjects not treated and followed by the Gastroenterology team at Mt. Sinai Hospital, Toronto"}, 'identificationModule': {'nctId': 'NCT02423460', 'briefTitle': 'Threonine Requirement in IBD Adults and Healthy Adult Controls', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': "Threonine Requirement in Healthy Adult Subjects and in Patients With Crohn's Disease and With Ulcerative Colitis Using the Indicator Amino Acid Oxidation (IAAO) Methodology", 'orgStudyIdInfo': {'id': '1000046356'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Threonine requirement', 'description': "The threonine requirement in healthy male subjects and in patients with Crohn's disease and Ulcerative colitis", 'interventionNames': ['Other: Threonine']}], 'interventions': [{'name': 'Threonine', 'type': 'OTHER', 'otherNames': ['amino acid'], 'description': "Threonine will be fed at various intake levels ranging from high to low in order to determine its requirement in healthy males and in patients with Crohn's disease and Ulcerative colitis.", 'armGroupLabels': ['Threonine requirement']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G-1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, {'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}