Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-05 @ 6:29 PM
Study NCT ID:
NCT02223169
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2014-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Intervention Study of Egg Protein Derivative on Cardiovascular Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2014-08-20', 'studyFirstSubmitQcDate': '2014-08-21', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A change between baseline blood pressure and endpoint blood pressure within the intervention group vs control group.', 'timeFrame': '42 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Blood Pressure', 'Hypertension', 'Cardiovascular disease'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Heart disease and stroke are the most common cause of death in Ireland today.One of the main risk factors for heart disease and stroke is high blood pressure or hypertension. Research has found that certain specific proteins or peptides found in foods such as dairy, meat, fish and eggs may promote heart health reducing blood pressure in adults with hypertension. The aim of this study is to investigate the potential beneficial effects egg peptides may have on heart health, in particular, effects on blood pressure.', 'detailedDescription': 'Poor dietary habits of Irish adults has been accompanied by epidemics of obesity and metabolic disorders such as type II diabetes leading to a substantial predicted increase in the prevalence of chronic diseases such as cardiovascular disease.Hypertension is a major contributing factor to the development of cardiovascular and metabolic diseases. Dietary factors play a significant role in the prevention and/or treatment of hypertension and therefore the development of foods with antihypertensive properties could prove beneficial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female\n* Non-diabetic\n* Aged 50-65\n* BMI 25-35kg/m²\n* Mild hypertensive: Blood pressure 130-149 mmHg\n\nExclusion Criteria:\n\n* Current smoker\n* Diagnosed hypertensive\n* History of cardiovascular disease\n* Diabetic\n* Chronic kidney disease\n* Gastrointestinal disease\n* Currently on anti-hypertensive medications\n* Allergic to eggs'}, 'identificationModule': {'nctId': 'NCT02223169', 'acronym': 'CardiProtein', 'briefTitle': 'Human Intervention Study of Egg Protein Derivative on Cardiovascular Risk', 'organization': {'class': 'OTHER', 'fullName': 'University College Cork'}, 'officialTitle': 'Dietary Intervention Study to Assess the Effects of Albumin-Derived Peptides on Cardio-Metabolic Risk Factors in Adults', 'orgStudyIdInfo': {'id': 'ECFP7-312090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Egg albumin-derived peptide', 'description': 'Each participant will consume 1 sachet of Egg albumin-derived peptide (3 g) each day mixed with a fruit juice drink for 42 days.', 'interventionNames': ['Dietary Supplement: Egg albumin-derived peptide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will consume one sachet of the placebo mixed with a fruit juice drink that will appear and taste similar to the albumin derived peptide sachet.', 'interventionNames': ['Dietary Supplement: Egg albumin-derived peptide']}], 'interventions': [{'name': 'Egg albumin-derived peptide', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Tensio-control'], 'description': 'Double-blind intervention study cross-over design with one sachet containing 3g Egg albumin-derived peptide (Tensio-control) or placebo (maltodextrin) in Phase one followed by cross-over in Phase 2.', 'armGroupLabels': ['Egg albumin-derived peptide', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cork', 'country': 'Ireland', 'facility': 'School of Food and Nutritional Sciences, UCC', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Cork', 'country': 'Ireland', 'facility': 'University College Cork', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}], 'overallOfficials': [{'name': 'Mairead Kiely, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College Cork'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College Cork', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mairead Kiely PhD', 'investigatorAffiliation': 'University College Cork'}}}}