Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-03 @ 8:21 PM
Study NCT ID:
NCT04094103
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2019-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strawberry Consumption in Overweight and Obese Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The supplement and placebo will be distributed to the individual by a member of the research team who is not involved with data collection or analysis.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2019-09-13', 'studyFirstSubmitQcDate': '2019-09-16', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in plasma lipids', 'timeFrame': 'Week 0, 4, 5, 9, 10, and 14', 'description': 'Total cholesterol (TC), LDL-c , VLDL-c, HDL-c , triglycerides (TG) from blood sample in a fasted state and following consumption of a meal'}], 'secondaryOutcomes': [{'measure': 'Change in glucose and insulin response', 'timeFrame': 'Week 0, 4, 5, 9, 10, and 14', 'description': 'Glucose, insulin, and c-peptide obtained from blood sample in a fasted state and in response to a meal'}, {'measure': 'Change in oxidixed LDL', 'timeFrame': 'Week 0, 4, 5, 9, 10, and 14', 'description': 'Obtained from blood sample in a fasted state and following consumption of a meal'}, {'measure': 'Change in homeostatic model assessment for insulin resistance', 'timeFrame': 'Week 0, 4, 5, 9, 10, and 14', 'description': 'Calculated from fasting glucose and insulin values'}, {'measure': 'Change in inflammation', 'timeFrame': 'Week 0, 4, 5, 9, 10, and 14', 'description': 'hs-CRP and IL-6 will be assessed in the fasted state from plasma'}, {'measure': 'Change in arterial stiffness', 'timeFrame': 'Week 0, 4, 5, 9, 10, and 14', 'description': 'Determined via changes in carotid artery stiffness calculated from simultaneous measurements of carotid artery diameter and pressure-waveforms'}, {'measure': 'Change in blood pressure (resting and 24-hr)', 'timeFrame': 'Week 0, 4, 5, 9, 10, and 14', 'description': 'Evaluated via automated sphygmomanometer. 24-hr ambulatory blood pressure is taken at 20-30 minute intervals over a 24hr period while the individual goes about their normal activities and while sleeping.'}, {'measure': 'Change in endothelial function', 'timeFrame': 'Week 0, 4, 5, 9, 10, and 14', 'description': 'Flow mediated dilation (FMD) assessed via a non-invasive 2D Doppler ultrasound following a 5-min period of arterial occlusion.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Our proposal represents an integrated approach to determining the cardiovascular and metabolic effects of strawberry consumption in adults who have high risk for cardiometabolic disease.', 'detailedDescription': 'The current proposal aims to fill some of these important research gaps with regard the dose and time-course of strawberry consumption in a population where dietary intervention may of particular benefit for both primary and secondary prevention of cardiovascular and metabolic disease. Participants will participate in a double blind, placebo-controlled, randomized crossover trial. Following a 10-day run-in where no berries are consumed, participants will be randomized via Latin-square design, to three different daily strawberry powder conditions for 4-weeks at a time, with a 7 day washout between conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overweight or obese by BMI (25.0-34.9kg/m2),\n* Borderline-high LDL-cholesterol (130-159mg/dL),\n* Normal or elevated blood pressure ((≤129mmHg/≤80mmHg)\n\nExclusion Criteria:\n\n* known allergy or intolerance to strawberries\n* taking any medications for chronic diseases including anti-inflammatory, anti-hypertensive, lipid-lowering, glucose-controlling, or steroidal medications\n* taking any supplements that might affect outcomes of the study including anti-oxidant or fish-oil supplements\n* having anemia or any liver, thyroid, renal conditions\n* current smoker or user of tobacco products, or use within the past three months\n* consuming alcohol (\\>1-2 drinks/day) on a regular basis\n* currently pregnant or lactating\n* having elevated blood pressure ≥130mmHg/≥80mmHg\n* presence of diagnosed diabetes mellitus, inflammatory disease, atherosclerotic disease, or other relevant chronic conditions\n* total cholesterol ≥240mg/dL\n* hemoglobin normal range values for males (between 13.0-17.5g/dL) and females (between 12.5-15.5g/dL)'}, 'identificationModule': {'nctId': 'NCT04094103', 'briefTitle': 'Strawberry Consumption in Overweight and Obese Individuals', 'organization': {'class': 'OTHER', 'fullName': 'Kansas State University'}, 'officialTitle': 'Integrated Cardiovascular and Metabolic Effects of Strawberry Consumption in Overweight and Obese Individuals', 'orgStudyIdInfo': {'id': 'Pro9736'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active strawberry powder', 'description': 'Participants will consume a 39g freeze-dried active strawberry powder beverage once per day for 4-weeks.', 'interventionNames': ['Dietary Supplement: Active strawberry powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo strawberry powder', 'description': 'Participants will consume a 39g freeze-dried strawberry powder placebo beverage once per day for 4-weeks.', 'interventionNames': ['Dietary Supplement: Placebo strawberry powder']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mixed active/placebo strawberry powder', 'description': 'Participants will consume a 39g mixed active/placebo strawberry powder beverage once per day for 4-weeks.', 'interventionNames': ['Dietary Supplement: Mixed strawberry powder']}], 'interventions': [{'name': 'Active strawberry powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will drink a strawberry beverage with active ingredients once a day during the 4-week intervention period.', 'armGroupLabels': ['Active strawberry powder']}, {'name': 'Placebo strawberry powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will drink a strawberry placebo beverage once a day during the 4-week intervention period.', 'armGroupLabels': ['Placebo strawberry powder']}, {'name': 'Mixed strawberry powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will drink a mixed strawberry beverage with active ingredients and placebo once a day during the 4-week intervention period.', 'armGroupLabels': ['Mixed active/placebo strawberry powder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66502', 'city': 'Manhattan', 'state': 'Kansas', 'country': 'United States', 'facility': 'Lafene Health Center', 'geoPoint': {'lat': 39.18361, 'lon': -96.57167}}], 'overallOfficials': [{'name': 'Sara Rosenkranz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kansas State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carl Ade, M.S., Ph.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'California Strawberry Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Co-Principal Investigator', 'investigatorFullName': 'Carl Ade, M.S., Ph.D.', 'investigatorAffiliation': 'Kansas State University'}}}}