Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT03020758
Status:
COMPLETED
Last Update Posted:
2023-08-18
First Post:
2017-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dried Fruit on Cardiometabolic Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-15', 'studyFirstSubmitDate': '2017-01-03', 'studyFirstSubmitQcDate': '2017-01-12', 'lastUpdatePostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fecal Microbiome', 'timeFrame': '4 weeks'}], 'primaryOutcomes': [{'measure': 'LDL Cholesterol', 'timeFrame': '4 weeks', 'description': 'serum low-density cholesterol concentration'}], 'secondaryOutcomes': [{'measure': 'HDL-cholesterol, non-HDL cholesterol, triglycerides', 'timeFrame': '4 weeks', 'description': 'serum concentrations of HDL and non-HDL cholesterol and triglycerides'}, {'measure': 'Central blood pressure', 'timeFrame': '4 weeks', 'description': 'central systolic and diastolic blood pressure'}, {'measure': 'Pulse wave velocity', 'timeFrame': '4 weeks', 'description': 'carotid-femoral pulse wave velocity'}, {'measure': 'Brachial blood pressure', 'timeFrame': '4 weeks', 'description': 'brachial systolic and diastolic blood pressure'}, {'measure': 'Plasma glucose', 'timeFrame': '4 weeks', 'description': 'fasting plasma glucose'}, {'measure': 'High-sensitivity C-reactive protein', 'timeFrame': '4 weeks', 'description': 'serum hs-CRP'}, {'measure': 'Serum insulin', 'timeFrame': '4 weeks', 'description': 'fasting serum insulin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a 2-period randomized crossover study with free-living subjects on self-selected diets. The objective of this study is to compare the effects of ¾ cup of a blend of dried plums, figs, dates and raisins (DPFDR) with an isocaloric and macronutrient matched snack food on blood pressure, vascular health and lipids and lipoproteins in 50 participants who are representative of the U.S. population and at risk for cardiovascular disease (overweight/obese, elevated LDL-cholesterol, prehypertension, and/or prediabetes).\n\nThe investigators hypothesize that the inclusion of DPFDR in the diet will decrease blood pressure and LDL-cholesterol, and improve artery function (assessed by standard blood pressure measure, 24 hr ambulatory blood pressure, central blood pressure and arterial stiffness) compared to the control group and baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index of 25-36 kg/m2\n\nAnd, at least one of the following:\n\n* LDL-C above 116 mg/dL (3.0 mmol/L)\n* Systolic blood pressure 120-159 mmHg\n* Diastolic blood pressure 80-99 mmHg\n* Increased waist circumference: ≥94 cm for men and ≥80 cm for women\n* Elevated glucose (≥ 100 mg/dL and \\< 126 mg/dL)\n* Triglycerides: above 150 mg/dL (1.69 mmol/L) and below 350 mg/dL (3.95 mmol/L)\n* Low HDL-cholesterol: \\<40 mg/dL (\\< 1.03 mmol/L) for men and \\< 50 mg/dL (\\<1.29 mmol/L) for women)\n\nExclusion Criteria:\n\n* Allergies to the test foods\n* History of cardiovascular disease, stage II hypertension (BP 160/100 mmHg), kidney disease, diabetes or inflammatory diseases such as gastrointestinal disorders and rheumatoid arthritis\n* Use of medication/supplements for elevated lipids, blood pressure, or glucose'}, 'identificationModule': {'nctId': 'NCT03020758', 'briefTitle': 'Effect of Dried Fruit on Cardiometabolic Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'The Effect of Bioactives in Dried Plums, Figs, Dates, and Raisins Compared With a High Carbohydrate Snack on Risk Factors for Cardiometabolic Disease', 'orgStudyIdInfo': {'id': 'PKE DRIED FRUIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dried Fruit', 'description': 'Daily consumption of ¾ cup blend of dried plums, figs, dates and raisins (DPFDR) for 4 weeks', 'interventionNames': ['Dietary Supplement: Dried Fruit']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Daily consumption of isocaloric and macronutrient matched snack food for 4 weeks', 'interventionNames': ['Other: High Carbohydrate Snack']}], 'interventions': [{'name': 'Dried Fruit', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Mixture of equal parts 4 dried fruits (figs, raisins, dates, plums) totaling 3/4 cup daily.', 'armGroupLabels': ['Dried Fruit']}, {'name': 'High Carbohydrate Snack', 'type': 'OTHER', 'description': 'Calorie-matched carbohydrate-rich snack.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16802', 'city': 'University Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State University', 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}], 'overallOfficials': [{'name': 'Penny Kris-Etherton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Nut and Dried Fruit Council', 'class': 'UNKNOWN'}, {'name': 'California Dried Plum Board', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}