Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2026-02-08 @ 9:07 AM
Study NCT ID:
NCT02717234
Status:
COMPLETED
Last Update Posted:
2023-05-01
First Post:
2016-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Appearance of Plasma Amino Acids Following Consumption of an Oral Nutrition Supplement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2016-03-11', 'studyFirstSubmitQcDate': '2016-03-17', 'lastUpdatePostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in plasma-free phospholipid Docosahexaenoic acid (DHA) in µg/ml', 'timeFrame': 'Pre-consumption, 30, 60, 120, 180, 240 minutes'}, {'measure': 'Change in plasma phospholipid Docosahexaenoic acid (DHA) in µg/ml', 'timeFrame': 'Pre-consumption, 30, 60, 120, 180, 240 minutes'}], 'primaryOutcomes': [{'measure': 'Change in plasma arginine levels in µmol/L', 'timeFrame': 'Pre-consumption, 30, 60, 120, 180, 240 minutes'}], 'secondaryOutcomes': [{'measure': 'Change in plasma-free phospholipid Eicosapentaenoic acid (EPA) in µg/ml', 'timeFrame': 'Pre-consumption, 30, 60, 120, 180, 240 minutes'}, {'measure': 'Change in plasma phospholipid Eicosapentaenoic acid (EPA) in µg/ml', 'timeFrame': 'Pre-consumption, 30, 60, 120, 180, 240 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'To assess the effect of consumption of an oral nutrition supplement on Arginine, a blood marker of nutritional intake'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy subject (absence of metabolic disorder, heart disease, endocrine disease, cancer)\n* Discontinued use of omega 3 fatty acid supplements - 10 days prior to testing\n* Willing to provide signed informed consent\n\nExclusion Criteria:\n\n* Smoker\n* Patients with potential for non-compliance\n* Patients with allergy to ingredients in test products (i.e. milk protein, fish oil)\n* Subject who in the Investigator's assessment cannot be expected to comply with study protocol\n* Currently participating in another conflicting clinical trial."}, 'identificationModule': {'nctId': 'NCT02717234', 'briefTitle': 'Appearance of Plasma Amino Acids Following Consumption of an Oral Nutrition Supplement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Appearance of Plasma Amino Acids Following Consumption of an Oral Nutrition Supplement', 'orgStudyIdInfo': {'id': '14.31.US.CLI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Impact Advanced Recovery', 'description': 'Oral nutrition supplement intended for consumption at 3 servings per day', 'interventionNames': ['Other: Oral Nutrition Supplement']}, {'type': 'EXPERIMENTAL', 'label': 'Impact Advanced Recovery-R', 'description': 'Oral nutrition supplement intended for consumption at 3 servings per day', 'interventionNames': ['Other: Oral Nutrition Supplement']}], 'interventions': [{'name': 'Oral Nutrition Supplement', 'type': 'OTHER', 'description': 'Oral nutrition supplement intended for consumption at 3 servings per day', 'armGroupLabels': ['Impact Advanced Recovery', 'Impact Advanced Recovery-R']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sherwyn Schwartz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diabetes & Glandular Disease Clinic, PA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}