Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-03 @ 9:31 PM
Study NCT ID:
NCT02052232
Status:
COMPLETED
Last Update Posted:
2016-06-17
First Post:
2013-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Protein Metabolism in Healthy Older Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-16', 'studyFirstSubmitDate': '2013-12-06', 'studyFirstSubmitQcDate': '2014-01-30', 'lastUpdatePostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Protein Metabolism', 'timeFrame': 'Change from - 1 to + 5 hours', 'description': 'Study Visit 1 and Study Visit 2'}], 'secondaryOutcomes': [{'measure': 'Macrovascular Blood Flow', 'timeFrame': 'Change from -1 to +5 hours', 'description': 'Study Visit 1 and Study Visit 2'}, {'measure': 'Glycemic Markers', 'timeFrame': 'Change from -1 to +5 hours', 'description': 'Study Visit 1 and Study Visit 2'}, {'measure': 'Microvascular Blood Flow', 'timeFrame': 'Change from -1 to +5 hours', 'description': 'Study Visit 1 and Study Visit 2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blinded, crossover study to evaluate muscle protein metabolism during fasting and feeding in healthy older subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 60 and ≤ 75 years\n* Body Mass Index (BMI) \\> 23.0 to \\< 30.0\n* Ability (with or without the aid of an assistive device) to climb a flight of 10 stairs or walk an equivalent of 1 city block without assistance\n* Currently not participating in a formal exercise or training program and agrees to refrain from intense physical activity from screening through the completion of the study.\n\nExclusion Criteria:\n\n* Diagnosis of diabetes\n* Active pursuit of weight loss\n* Poorly controlled hypertension or hypotension\n* Untreated hypothyroidism or hyperthyroidism\n* Anemia or abnormally functioning kidneys or liver\n* A significant cardiovascular event within ≤ 6 months; or stated history of congestive heart failure; or evidence of clinically active cardiovascular disease assessed during the screening EKG\n* Peripheral arterial disease or other diseases that preclude proper limb blood flow\n* Chronic, contagious, infectious disease\n* Current infection or corticosteroid treatment within the last 3 months\n* Clotting or bleeding disorders, stated history of Deep Vein Thrombosis (DVT) and/or a known hypercoagulable condition\n* In condition deemed unsuitable for study based upon study physician assessment\n* Surgery requiring \\>2 days of hospitalization in the last 3 weeks and/or planned elective surgery requiring \\>2 days of hospitalization during the course of the study\n* Current active malignant disease or was treated within the last 6 months for cancer\n* An amputee\n* Obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease\n* Diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse\n* Cannot refrain from taking\n\n * High doses of fish oil, or omega-3 supplements, or high doses of vitamin D\n * Medications/dietary supplements/herbals or substances that are considered anabolic, or reduce weight\n * Any pulmonary anti-inflammatory medication or bronchodilators on the day of and 48 hours prior to study visits 1 and 2\n * NSAIDS or acetaminophen on the day of and 48 hours prior to study visits 1 and 2\n* Chronic use of nicotine\n* Allergic or intolerant to any ingredient found in the study products'}, 'identificationModule': {'nctId': 'NCT02052232', 'briefTitle': 'Study of Protein Metabolism in Healthy Older Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Study of Acute Muscle Protein Metabolism in Healthy Older Subjects', 'orgStudyIdInfo': {'id': 'BL19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control protein powder sachet', 'interventionNames': ['Other: Control protein powder sachet']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Experimental protein powder sachet', 'interventionNames': ['Other: Experimental protein powder sachet']}], 'interventions': [{'name': 'Experimental protein powder sachet', 'type': 'OTHER', 'description': 'mixed with 8 oz. water', 'armGroupLabels': ['Experimental']}, {'name': 'Control protein powder sachet', 'type': 'OTHER', 'description': 'mixed with 8 oz. water', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DE22 3DT', 'city': 'Derby', 'country': 'United Kingdom', 'facility': 'University of Nottingham', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}], 'overallOfficials': [{'name': 'Min Tian, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}