Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-27 @ 11:18 PM
Study NCT ID:
NCT04234334
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2020-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefits of Eggs in Combination With a Plant-based Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Egg or Egg substitutes (whites only) will be provided to subjects and since they are similar in appearance and color, they will not know when they are consuming them'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized Crossover design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2020-01-13', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma lutein', 'timeFrame': '1 year', 'description': 'Plasma lutien will be measured by HPLC. The units are expresses as µmol/L'}, {'measure': 'Plasma choline', 'timeFrame': '1 year', 'description': 'It will be measured by mass spectometry. The units are expressed as nmol/mL'}, {'measure': 'Plasma Zeaxanthin', 'timeFrame': '1 year', 'description': 'Plasma zeaxanthin will by measured by HPLC. The units are expressed as µmol/L'}], 'secondaryOutcomes': [{'measure': 'Plasma lipids', 'timeFrame': '1 year', 'description': 'Total, LDL and HDL cholesterol and triglycerides will be measured by an automated spectrometer simultaneously. The units are expressed as mg/dL'}, {'measure': 'Plasma glucose', 'timeFrame': '1 Year', 'description': 'Plasma glucose will be measured by an automated spectrometer. Units are expressed as mg/dL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eggs', 'lutein', 'zeaxanthin', 'choline', 'metabolic syndrome', 'plant-based diet'], 'conditions': ['Coronary Artery Disease', 'Diabetes', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to demonstrate that the inclusion of eggs to a plant-based diet will not increase the risk for heart disease but will increase the concentration of lutein and zeaxanthin, two important antioxidants and will also increase choline, an important component of membrane phospholipids.', 'detailedDescription': 'Results from studies involving cells, animal models and clinical trials have demonstrated that lutein and zeaxanthin potentially protect against chronic diseases, including age-related macular degeneration, cataracts, coronary heart disease and stroke. Plasma concentrations of lutein and zeaxanthin are closely associated with their antioxidant properties and with their protection against reactive oxygen species (ROS).\n\nCholine is recognized as an essential nutrient for health because of its many functions in growth and development, as well as neurological function and formation of membrane phospholipids, including phosphatidylcholine (PC) and sphingomyelin.\n\nTherefore the objective of this study is to demonstrate that inclusion of eggs in a plant-based diet will potentiate the benefits of this healthy diet by increasing plasma concentrations of lutein, zexanthin and choline presents in egg yolks and theoretically increase the antioxidant and anti-inflammatory actions of these components. This would be potentially more important in those individuals with metabolic syndrome, which is the target population of this intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All genders\n* 35-70 years\n* Metabolic syndrome (based on 3 out of 5 characteristics: waist circumference. 88 cm for women and \\> 102 cm for men; plasma triglycerides \\> 150 mg/dL, blood pressure \\> 135/85 mm Hg, fasting glucose \\> 100 mg/dL and HDL \\< 40 mg/dL for men and \\< 50 mg/dL for women)\n* Willing to consume a spinach omelet made with 2 eggs or the equivalent amount of egg substitute daily for 4 weeks each\n* Willing to follow a plant-based diet for 13 weeks\n* Not have cardiovascular disease, high cholesterol, diabetes, cancer, liver or renal disease\n* Proficient in English\n\nExclusion Criteria:\n\n* Self-reported diabetes, cardiovascular disease, history of stroke, liver disease or cancer\n* Taking glucose lowering medications\n* Triglycerides \\> 500 mg/dL\n* Cholesterol \\> 240 mg/dL\n* Blood pressure \\> 145/100 mm Hg\n* Allergic to eggs or spinach'}, 'identificationModule': {'nctId': 'NCT04234334', 'briefTitle': 'Benefits of Eggs in Combination With a Plant-based Diet', 'organization': {'class': 'OTHER', 'fullName': 'University of Connecticut'}, 'officialTitle': 'Evaluation of the Role of Eggs on Antioxidant Status, Plasma Choline and Lipoprotein Metabolism in Adults With Metabolic Syndrome Consuming a Plant-based Diet', 'orgStudyIdInfo': {'id': 'H19-178'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Egg intake', 'description': 'Consumption of 2 eggs with spinach daily for breakfast for 4 weeks', 'interventionNames': ['Other: Consume 2 eggs with spinach per day']}, {'type': 'EXPERIMENTAL', 'label': 'Egg Subsitute', 'description': 'Consumption of 2 egg substitutes daily for breakfast for 4 weeks', 'interventionNames': ['Other: Egg Subsitute with spinach per day']}], 'interventions': [{'name': 'Consume 2 eggs with spinach per day', 'type': 'OTHER', 'otherNames': ['Egg substitute'], 'description': 'Participants will be randomly allocated to consume either 2 eggs or 2 egg substitutes with spinach daily for 4 weeks and after a 3-week wash out, they will be allocated to the alternate treatment', 'armGroupLabels': ['Egg intake']}, {'name': 'Egg Subsitute with spinach per day', 'type': 'OTHER', 'description': 'Egg Subsitute with spinach per day', 'armGroupLabels': ['Egg Subsitute']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06269', 'city': 'Storrs', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Department of Nutritional Sciences', 'geoPoint': {'lat': 41.80843, 'lon': -72.24952}}], 'overallOfficials': [{'name': 'Maria-Luz Fernandez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Connecticut'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Connecticut', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Egg Board', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Maria Luz Fernandez', 'investigatorAffiliation': 'University of Connecticut'}}}}