Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT03441620
Status:
COMPLETED
Last Update Posted:
2021-03-16
First Post:
2018-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Strawberries on Blood Cholesterol.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-12', 'studyFirstSubmitDate': '2018-02-05', 'studyFirstSubmitQcDate': '2018-02-14', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Lipid profiles', 'timeFrame': '14 weeks', 'description': 'Serum LDL, total and HDL cholesterol, triglycerides'}, {'measure': 'Glycemic control', 'timeFrame': '14 weeks', 'description': 'Blood glucose'}, {'measure': 'Serum lipid particle concentrations', 'timeFrame': '14 weeks', 'description': 'Molar concentrations of serum lipids and particle size'}, {'measure': 'Diabetes control', 'timeFrame': '14 weeks', 'description': 'Insulin resistance'}], 'secondaryOutcomes': [{'measure': 'Systemic Inflammation', 'timeFrame': '14 weeks', 'description': 'Serum C-reactive protein and adipokines'}, {'measure': 'Systemic Anthocyanins', 'timeFrame': '14 weeks', 'description': 'Strawberry anthocyanin metabolites measured in serum'}, {'measure': 'Serum metabolomics', 'timeFrame': '14 weeks', 'description': 'primary and lipid metabolites in serum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyper-LDL-cholesterolemia', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'In this study, we propose to investigate the effects of dietary achievable doses of strawberries on serum LDL-cholesterol (LDL-C) and related lipid profiles, measures of glycemia and insulin resistance, and biomarkers of inflammation in a 14 week controlled crossover study.', 'detailedDescription': 'The screen visit will involve an 8 hour fasting state and the following procedures:\n\n* Completing screening questionnaire\n* Measuring height, weight, blood pressure, and waist size\n* Drawing about 30mL blood for blood glucose and lipids and comprehensive metabolic panel All subjects will be asked to follow usual diet and lifestyle, and refrain from other sources of berries and related products while on the study. Subjects will also maintain 3-day food records at screen, 4, 9, and 14 weeks of the study. Height, weight, blood pressure and waist circumference will be measured by trained personnel at MPE 326 (KNS facility for clinical research). Blood draws will be performed by trained phlebotomists (to be hired) at MPE 326, and all procedures will be performed by trained research personnel \\[PI \\&Co-PI: Basu, Izuora and graduate student\\]. In case of blood pressure, an average of at least three readings, 10 min apart, will be measured at each visit for each participant. Blood glucose (fasting and postprandial at two hours) will be determined at each time point. The oral glucose tolerance tests will be conducted at MPE 326 and blood samples will be sent to Quest Diagnostics, Las Vegas. Insulin resistance will be calculated using the homoeostatic model assessment (HOMA-IR). The HOMA-IR is a standard and widely used formula in calculating insulin resistance based on fasting glucose values. Screening and follow-up tests will include clinical laboratory tests for blood glucose, lipids, NMR profiles, C-reactive protein and metabolic panel to determine effects of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elevated total and LDL cholesterol (\\>116 mg/dL)\n* body mass index (\\> or = 30 kg/m2)\n* features of the metabolic syndrome\n\nExclusion Criteria:\n\n* taking glucose and lipid lowering medications (e.g. statins, metformin)\n* history of chronic conditions (diabetes, CHD, anemia, renal diseases)\n* allergic to strawberries\n* pregnant and/or lactating\n* smoking\n* vegetarian or consuming special diet'}, 'identificationModule': {'nctId': 'NCT03441620', 'briefTitle': 'The Effects of Strawberries on Blood Cholesterol.', 'organization': {'class': 'OTHER', 'fullName': 'University of Nevada, Las Vegas'}, 'officialTitle': 'Effects of Strawberries on LDL Cholesterol and Insulin Resistance in Overweight/Obese Adults With the Metabolic Syndrome.', 'orgStudyIdInfo': {'id': '1119274'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Calorie and fiber-matched control powder', 'interventionNames': ['Other: Control powder']}, {'type': 'EXPERIMENTAL', 'label': 'Strawberry one serving', 'description': 'Freeze-dried powder equivalent to one serving fresh strawberries per day.', 'interventionNames': ['Dietary Supplement: strawberries']}, {'type': 'EXPERIMENTAL', 'label': 'Strawberry two-half servings', 'description': 'Freeze-dried powder equivalent to 2.5 serving fresh strawberries per day.', 'interventionNames': ['Dietary Supplement: strawberries']}], 'interventions': [{'name': 'strawberries', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Freeze-dried strawberry powder', 'armGroupLabels': ['Strawberry one serving', 'Strawberry two-half servings']}, {'name': 'Control powder', 'type': 'OTHER', 'description': 'Control powder matched for fiber and strawberries', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89154', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'University of Nevada at Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center, OCTSI', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74078', 'city': 'Stillwater', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma State University', 'geoPoint': {'lat': 36.11561, 'lon': -97.05837}}], 'overallOfficials': [{'name': 'Arpita Basu, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nevada at Las Vegas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nevada, Las Vegas', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oklahoma', 'class': 'OTHER'}, {'name': 'Oklahoma State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Arpita Basu', 'investigatorAffiliation': 'University of Nevada, Las Vegas'}}}}