Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT01412658
Status:
COMPLETED
Last Update Posted:
2011-08-09
First Post:
2011-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Safety of a Novel Milk Protein Peptide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-08', 'studyFirstSubmitDate': '2011-08-07', 'studyFirstSubmitQcDate': '2011-08-08', 'lastUpdatePostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood and Hormones', 'timeFrame': '6 weeks', 'description': 'General whole blood and serum clinical chemistries (cholesterol, triglycerides, glucose, blood urea nitrogen, creatinine, uric acid, muscle and liver enzymes) and hormones (insulin, homeostasis model of insulin sensitivity, and leptin).'}], 'secondaryOutcomes': [{'measure': 'Psychosocial', 'timeFrame': '6 weeks', 'description': 'quality of life indices'}, {'measure': 'Body Composition', 'timeFrame': '6 weeks', 'description': 'All participants were tested for changes in energy intake and body composition'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Drug Safety']}, 'referencesModule': {'references': [{'pmid': '21943352', 'type': 'DERIVED', 'citation': 'Kreider RB, Iosia M, Cooke M, Hudson G, Rasmussen C, Chen H, Mollstedt O, Tsai MH. Bioactive properties and clinical safety of a novel milk protein peptide. Nutr J. 2011 Sep 26;10:99. doi: 10.1186/1475-2891-10-99.'}], 'seeAlsoLinks': [{'url': 'http://exerciseandsportnutritionlab.com/', 'label': 'Exercise \\& Sport Nutrition Lab'}]}, 'descriptionModule': {'briefSummary': 'Background: A novel milk peptide has been shown in laboratory setting to have natural anti-cancer properties and extend lifespan and improve metabolism in animal models. The purpose of this study was 1.) to determine the safety dosage range and, 2.) to determine whether this novel milk peptide positively influence blood markers, metabolism and improve quality of life.', 'detailedDescription': 'The study was conducted as a randomized, double-blind, placebo-controlled clinical trial in a university research setting. Healthy volunteers were randomly assigned to ingest in a double-blind and randomized manner either a placebo or milk peptides. Outcome measures were assessed at 0, 3, and 6 weeks of supplementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects with body mass index between 27-40.\n\nExclusion Criteria:\n\n* have any metabolic disorders including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, thyroid disease or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurologic disease; if they are taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications;\n* have milk allergies'}, 'identificationModule': {'nctId': 'NCT01412658', 'briefTitle': 'Clinical Safety of a Novel Milk Protein Peptide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ambryx Biotechnology'}, 'officialTitle': 'Safety Study of Milk Peptide Supplementation in Healthy Volunteers: a Randomized Placebo Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'AX_Safety_study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Milk Peptides', 'interventionNames': ['Dietary Supplement: Hydrolyzed milk protein mixture']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "Participants ingested 6ml - 21ml (based on participants' weight) of clear, sugar-less liquid placebo mixed with 1/2 cup milk twice daily (once immediately after breakfast and once immediately after dinner). The supplements were prepared in liquid form and packaged in generic bottles for double blind administration. The placebo was a glycerol-based placebo matched for color, texture, and taste to the active supplement.", 'interventionNames': ['Dietary Supplement: Glycerol placebo']}], 'interventions': [{'name': 'Hydrolyzed milk protein mixture', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['AX-4'], 'description': 'Take twice a day, dosage 6 ml-21 ml based on weight, mix with 1/2 cup of milk.', 'armGroupLabels': ['Milk Peptides']}, {'name': 'Glycerol placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants ingested 6ml-21ml of placebo mixed with 1/2 cup milk twice daily. The supplements were prepared in liquid form and packaged in generic bottles for double blind administration. The placebo was a starch-based placebo matched for color, texture, and taste to the active supplement.\n\nA food diary is maintained daily.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76706', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor University Center for Exercise, Nutrition, and Preventive Health Research', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}], 'overallOfficials': [{'name': 'Rick Kreider, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas A&M University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ambryx Biotechnology', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Texas A&M University', 'class': 'OTHER'}, {'name': 'Baylor University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Richard B Kreider, PhD', 'oldOrganization': 'Texas A&M University'}}}}