Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-02-24 @ 12:26 AM
Study NCT ID:
NCT02737293
Status:
TERMINATED
Last Update Posted:
2022-08-04
First Post:
2016-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole Egg Intake and the Mediterranean Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-07', 'size': 552026, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-01-18T11:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'whyStopped': 'Due to COVID-19 and expiration of grant funds', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2016-03-31', 'studyFirstSubmitQcDate': '2016-04-07', 'lastUpdatePostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in lipoprotein metabolism', 'timeFrame': 'baseline and 4 weeks', 'description': 'Assess lipid metabolism response to the intervention.'}], 'secondaryOutcomes': [{'measure': 'Change in inflammatory markers', 'timeFrame': 'baseline and 4 weeks', 'description': 'Determine inflammatory marker response to the intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight', 'Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/', 'label': 'Grand Forks Human Nutrition Research Center Current Nutrition Studies'}]}, 'descriptionModule': {'briefSummary': 'This project will evaluate the daily intake of whole eggs in the Mediterranean Diet (Med Diet). Cholesterol levels are normally related to cardiovascular disease (CVD) risk. Dietary fat and the total diet makeup are well known modifiers of CVD risk. The Med Diet has been shown to decrease blood lipids (fats) and reduce inflammation. Cholesterol intake from eggs may not be as bad as once thought and, in fact, may help to improve the blood lipid (fat) levels. This study is being done to test how the addition of eggs to a Med Diet affects blood lipids and other risk markers for CVD.', 'detailedDescription': 'Elevated serum cholesterol is a major contributor to cardiovascular disease (CVD), which is responsible for \\~1/3 of all deaths in the US. However, about 50% of those who experience heart attacks have normal cholesterol levels. Cholesterol is carried in lipoproteins (HDL, LDL, and VLDL) and the amount in circulation is used to evaluate CVD risk. However, the particle size and density of lipoprotein subfractions may be more predictive for atherogenesis than their total levels. Dietary fatty acids are well recognized modulators of lipoproteins, and ultimately CVD risk. Saturated and trans fatty acids have a negative effect on CVD risk while poly- and monounsaturated fatty acids (PUFA, MUFA) appear to be protective. The Mediterranean Diet (Med Diet) decreases atherogenic lipoproteins and reduces systemic inflammation. It is unknown how high cholesterol intake within a Med Diet will affect these parameters, although recent evidence implies that the fatty acid content of the diet is more important than the cholesterol content. Therefore, this project will evaluate the daily inclusion of whole eggs, a high cholesterol food, in the Med Diet on lipid profiles, lipoprotein particle size and density and biomarkers of systemic inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willingness to comply with the demands of the experimental protocol\n* Not performing vigorous exercise \\>2 times per week\n* BMI 25-39.9 kg/m2\n* Non-nicotine-using\n\nExclusion Criteria:\n\n* Have an egg allergy\n* Have diabetes\n* Have high triglyceride levels\n* Have uncontrolled high blood pressure\n* Have used tobacco products or nicotine in any form including snuff, pills and patches, or e-cigarettes in the previous 6 months\n* Use prescription medications or over-the-counter lipid lowering drugs (such as statins) or anti-inflammatory medications (such as aspirin, ibuprofen or Aleve) on a regular basis\n* Take omega 3 supplements, plant sterols or sterol esters\n* Are pregnant or lactating\n* Have been diagnosed with an eating disorder\n* Inability to give consent\n* Unwillingness or inability to consume the treatment diets'}, 'identificationModule': {'nctId': 'NCT02737293', 'briefTitle': 'Whole Egg Intake and the Mediterranean Diet', 'organization': {'class': 'FED', 'fullName': 'USDA Grand Forks Human Nutrition Research Center'}, 'officialTitle': 'Whole Egg Intake and the Mediterranean Diet', 'orgStudyIdInfo': {'id': 'GFHNRC147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control Diet', 'description': 'Menu based on the average American diet.', 'interventionNames': ['Other: Control Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Med Diet', 'description': 'Menu based on the typical Mediterranean diet (Med Diet) pattern.', 'interventionNames': ['Other: Med Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Med Diet + Whole Egg', 'description': 'Menu based on the typical Mediterranean diet (Med Diet) pattern with the addition of 1 whole egg per 1000 kilocalories.', 'interventionNames': ['Other: Med Diet + Whole Egg']}], 'interventions': [{'name': 'Control Diet', 'type': 'OTHER', 'description': '4-week intake of Control Diet 5 day rotating menu', 'armGroupLabels': ['Control Diet']}, {'name': 'Med Diet', 'type': 'OTHER', 'description': '4-week intake of Med Diet 5 day rotating menu', 'armGroupLabels': ['Med Diet']}, {'name': 'Med Diet + Whole Egg', 'type': 'OTHER', 'description': '4-week intake of Med Diet plus Whole Egg 5 day rotating menu', 'armGroupLabels': ['Med Diet + Whole Egg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58203', 'city': 'Grand Forks', 'state': 'North Dakota', 'country': 'United States', 'facility': 'USDA Grand Forks Human Nutrition Research Center', 'geoPoint': {'lat': 47.92526, 'lon': -97.03285}}], 'overallOfficials': [{'name': 'Matthew Picklo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USDA Grand Forks Human Nutrition Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA Grand Forks Human Nutrition Research Center', 'class': 'FED'}, 'collaborators': [{'name': 'Egg Nutrition Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}