Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-24 @ 10:55 AM
Study NCT ID:
NCT02732158
Status:
COMPLETED
Last Update Posted:
2017-03-27
First Post:
2016-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Laboratory Methods in Nutrition Studies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-23', 'studyFirstSubmitDate': '2016-04-04', 'studyFirstSubmitQcDate': '2016-04-07', 'lastUpdatePostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of lab values from venipuncture and DBS methods', 'timeFrame': 'Baseline', 'description': 'Correlation and difference in baseline levels of AN777 and carotenoids between samples collected through venipuncture and fingerstick on dried blood spot (DBS) cards.'}], 'secondaryOutcomes': [{'measure': 'Change in AN777', 'timeFrame': 'Baseline to Day 60'}, {'measure': 'Change in carotenoids', 'timeFrame': 'Baseline to Day 60'}, {'measure': 'Compliance of study product consumption', 'timeFrame': 'Baseline to Day 60', 'description': 'Subject Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Novel laboratory methods'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This prospective, nonrandomized, feasibility study will compare laboratory measures at the beginning and end of the study period in adults consuming a nutritional study product.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must agree to refrain from taking supplements other than study product.\n* Participant states willingness to follow protocol as described, including consumption of study product per protocol, performing finger stick/DBS on Day 60 and completing any forms needed throughout the study.\n\nExclusion Criteria:\n\n* Body Mass Index (BMI) \\> or equal to 35 kg/m2\n* Has planned elective surgery requiring 2 or more days of hospitalization during the entire study\n* Has stated active malignant disease\n* Has a known history of chronic renal parenchymal disease\n* Has a known history of severe liver disease/liver failure\n* Has any psychiatric disorders that would interfere with study product consumption or compliance with the study procedures\n* Known allergy or intolerance to any study product ingredient\n* Participation in another study that has not been approved as a concomitant study'}, 'identificationModule': {'nctId': 'NCT02732158', 'briefTitle': 'Novel Laboratory Methods in Nutrition Studies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Feasibility of Novel Laboratory Methods for Use in Nutrition Studies', 'orgStudyIdInfo': {'id': 'BL27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutrition Products', 'description': 'Two servings per day of the sachet study product mixed with water; 1 carotenoid capsule per day', 'interventionNames': ['Other: Nutrition Products']}], 'interventions': [{'name': 'Nutrition Products', 'type': 'OTHER', 'description': 'a sachet containing AN777and amino acids; a carotenoid capsule', 'armGroupLabels': ['Nutrition Products']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77843-4253', 'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas A&M University, Center for Translation Research in Aging and Longevity', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}], 'overallOfficials': [{'name': 'Carolyn Alish, PhD, RD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}