Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT06735651
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2024-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D006940', 'term': 'Hyperemia'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reactive Hyperemia Index', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Assessment of endothelial function in response to increased shear stress using EndoPAT2000'}, {'measure': 'Pulse Wave Velocity', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Arterial Stiffness will be assessed by pulse wave velocity using SphygmCor'}, {'measure': 'Percent Maximal Microvascular Blood Flow', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Micro-vessel blood flow in response to local heating stimulus will be assessed using a Laser Doppler'}, {'measure': 'Circulating Markers of Inflammation and Oxidative Stress', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Measurement of concentrations of circulating markers of inflammation such as CRP and oxidative stress such as TBARS in blood plasma and serum samples.'}, {'measure': 'Urinary Polyphenolic Metabolites', 'timeFrame': 'Baseline and 6 weeks', 'description': '24-hour urine collection samples will be assessed for polyphenol metabolites'}, {'measure': 'Body Fat', 'timeFrame': 'Baseline and 6 weeks', 'description': 'DEXA will be used to assess body fat.'}], 'primaryOutcomes': [{'measure': 'Blood Glucose', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Measurement of fasting blood glucose'}, {'measure': 'Ambulatory Blood Pressure', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Assessment of whole-day ambulatory blood pressure during daytime and nighttime periods.'}], 'secondaryOutcomes': [{'measure': 'Fasting Insulin', 'timeFrame': 'Baseline and 6 weeks'}, {'measure': 'Homeostasis model assessment-insulin resistance (HOMA-R)', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL)/405'}, {'measure': 'Blood Lipid Profile', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Measurement of blood lipid profile'}, {'measure': 'Gut Microbiota Composition', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Analysis of stool sample for determination of absolute levels of bacteria and relative species composition'}, {'measure': 'Global Cognitive Ability', 'timeFrame': 'Screening', 'description': 'Measured using NIH Toolbox Picture Vocabulary test and Oral Reading Recognition'}, {'measure': 'Performance Validity', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Assessed using Rey 15'}, {'measure': 'Verbal Memory & Recognition', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Measured using Rey Auditory Verbal Learning Test with appropriate alternate forms'}, {'measure': 'Cognitive Inhibition', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Measured using Delis-Kaplan Executive Function System Color Word Interference, and NIH Toolbox Flanker Inhibitory Control and Attention'}, {'measure': 'Cognitive Flexibility', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Assessed using Delis-Kaplan Executive Function System Trails and Verbal Fluency Switching'}, {'measure': 'Working Memory', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Measured using Digit Span and NIH Toolbox List Sorting'}, {'measure': 'Processing Speed', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Measured using NIH Toolbox Pattern Comparison and Oral Symbol Digit tests'}, {'measure': 'Associative Memory', 'timeFrame': 'Baseline and 6 months', 'description': 'Measured using NIH Toolbox Face Name Associative Memory Exam and Face Name Associative Memory Exam Delay tests'}, {'measure': 'Attention', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Assessed using Wechsler Adult Intelligence Scale - IV and Rey Auditory Verbal Learning Test Trial 1.'}, {'measure': 'Problem-Solving', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Assessed using NIH Toolbox Visual Reasoning Test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blueberries', 'Prediabetes', 'Insulin Resistance', 'Functional foods', 'Dietary intervention', 'Endothelial function', 'Vascular function', 'Cardiovascular health', 'Metabolic health', 'Gut microbiota', 'Cognitive function', 'Type II diabetes', 'Microvascular Function', 'Wild Blueberries'], 'conditions': ['Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)', 'Female', 'Adult', 'Endothelial Function (Reactive Hyperemia)', 'Arterial Stiffness', 'Cognition', 'Oxidative Stress', 'Gut Microbiota', 'Overweight', 'Inflammation', 'Microvascular Function', 'Body Composition']}, 'referencesModule': {'references': [{'pmid': '32337475', 'type': 'BACKGROUND', 'citation': 'Stote KS, Wilson MM, Hallenbeck D, Thomas K, Rourke JM, Sweeney MI, Gottschall-Pass KT, Gosmanov AR. Effect of Blueberry Consumption on Cardiometabolic Health Parameters in Men with Type 2 Diabetes: An 8-Week, Double-Blind, Randomized, Placebo-Controlled Trial. Curr Dev Nutr. 2020 Mar 9;4(4):nzaa030. doi: 10.1093/cdn/nzaa030. eCollection 2020 Apr.'}, {'pmid': '28283823', 'type': 'BACKGROUND', 'citation': 'Miller MG, Hamilton DA, Joseph JA, Shukitt-Hale B. Dietary blueberry improves cognition among older adults in a randomized, double-blind, placebo-controlled trial. Eur J Nutr. 2018 Apr;57(3):1169-1180. doi: 10.1007/s00394-017-1400-8. Epub 2017 Mar 10.'}, {'pmid': '30022099', 'type': 'BACKGROUND', 'citation': 'Biessels GJ, Despa F. Cognitive decline and dementia in diabetes mellitus: mechanisms and clinical implications. Nat Rev Endocrinol. 2018 Oct;14(10):591-604. doi: 10.1038/s41574-018-0048-7.'}, {'pmid': '28402770', 'type': 'BACKGROUND', 'citation': 'Rawshani A, Rawshani A, Franzen S, Eliasson B, Svensson AM, Miftaraj M, McGuire DK, Sattar N, Rosengren A, Gudbjornsdottir S. Mortality and Cardiovascular Disease in Type 1 and Type 2 Diabetes. N Engl J Med. 2017 Apr 13;376(15):1407-1418. doi: 10.1056/NEJMoa1608664.'}, {'pmid': '35458181', 'type': 'BACKGROUND', 'citation': 'Krikorian R, Skelton MR, Summer SS, Shidler MD, Sullivan PG. Blueberry Supplementation in Midlife for Dementia Risk Reduction. Nutrients. 2022 Apr 13;14(8):1619. doi: 10.3390/nu14081619.'}, {'pmid': '25578927', 'type': 'BACKGROUND', 'citation': 'Johnson SA, Figueroa A, Navaei N, Wong A, Kalfon R, Ormsbee LT, Feresin RG, Elam ML, Hooshmand S, Payton ME, Arjmandi BH. Daily blueberry consumption improves blood pressure and arterial stiffness in postmenopausal women with pre- and stage 1-hypertension: a randomized, double-blind, placebo-controlled clinical trial. J Acad Nutr Diet. 2015 Mar;115(3):369-377. doi: 10.1016/j.jand.2014.11.001. Epub 2015 Jan 8.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine the effectiveness of using a freeze-dried wild blueberry powder on cardiometabolic health, cognitive function, and gut microbiota composition in adult women with prediabetes.', 'detailedDescription': 'In the U.S., 35.3 million adults have type 2 diabetes mellitus (T2DM) and 96 million have prediabetes. Eight out of 10 people with T2DM die from cardiovascular disease. People with T2DM also have a 50% higher risk of developing dementia compared to healthy counterparts. Further, studies show that gut microbes play a major role in the development of T2DM. Prevention and treatment of T2DM focus on lifestyle changes including dietary modifications such as increased consumption of deep-colored fruits like berries. Blueberries are rich in fiber and phytochemicals and have several health benefits. We and others have shown that blueberry intake improves heart health in healthy men, hypertensive postmenopausal women, and men and women with metabolic syndrome. Yet, a comprehensive study in women with prediabetes that measures changes in cognitive performance and the underlying heart and gut health has not been conducted to date. Thus, the overall objective of this study is to investigate and bring forth evidence that wild blueberries improve gut, cardiometabolic, and cognitive function in women with prediabetes.\n\nTherefore, this pilot six-week randomized, placebo-controlled parallel-arm clinical trial aims to investigate whether daily consumption of 22 g of freeze-dried wild blueberry powder improves gut, cardiometabolic, and cognitive function in women with prediabetes. Investigators hypothesize that daily consumption of wild blueberries will improve cardiometabolic parameters, gut dysbiosis, and cognitive impairments in our study population. To test these hypotheses, the following specific aims are proposed. To investigate whether daily consumption of 22 g of freeze-dried wild blueberry powder:\n\n* Reduces levels of fasting blood glucose (FBG), insulin, and HOMA-IR (homeostatic model assessment of insulin resistance) and improves lipid profile in women with prediabetes.\n* Reduces blood pressure and improves endothelial function in women with prediabetes.\n* Improves cognitive function (verbal memory and executive functions \\[inhibition, working memory, cognitive flexibility\\]) in women with prediabetes.\n* Favorably modulates gut microbiota composition in women with prediabetes.\n* Improves serum markers of oxidative stress and inflammation in women with prediabetes.\n\nAdditionally, whether changes in the gut microbiota are associated with changes in cardiometabolic and cognitive function outcomes and whether changes in cardiometabolic outcomes are associated with changes in cognitive function parameters will be explored.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 45-65 years old\n* Prediabetes (fasting blood glucose 100-125 mg/dL and/or HbA1c percentage between 5.7-6.4)\n* Body Mass Index between 25-30 kg/m\\^2\n\nExclusion Criteria:\n\n* Allergies to berries\n* Use of insulin, antidiabetic, antibiotics, and anti-inflammatory drugs\n* Active cancer, gastrointestinal, renal, thyroid, stage 1 \\& 2 hypertension and other cardiovascular diseases, neurological diseases, or severe head injury\n* Smoking\n* Consumes greater than 2 alcoholic beverages per day\n* Consumes antioxidant, probiotic, and prebiotic supplements\n* Pregnant or Lactating\n* Actively participating in a weight loss program\n* Currently taking berry supplements or recently participated in another study taking berry supplements'}, 'identificationModule': {'nctId': 'NCT06735651', 'briefTitle': 'Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes', 'organization': {'class': 'OTHER', 'fullName': 'Georgia State University'}, 'officialTitle': 'Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Female Adults With Prediabetes.', 'orgStudyIdInfo': {'id': 'H24123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wild Blueberry', 'description': '22 g of freeze-dried wild blueberry freeze-dried powder per day', 'interventionNames': ['Dietary Supplement: Wild Blueberry']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '22 g of freeze-dried macronutrient-matched placebo powder per day', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Wild Blueberry', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily consumption of 22 g of freeze-dried wild blueberry freeze-dried powder for 6 weeks', 'armGroupLabels': ['Wild Blueberry']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily consumption of 22 g of freeze-dried macronutrient-matched placebo powder for 6 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rafaela G Feresin, PhD', 'role': 'CONTACT', 'email': 'berries@gsu.edu', 'phone': '404-413-1233'}, {'name': 'Rafaela G Feresin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andrew Gerwitz, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tricia Z King, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Brett J Wong, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elizabeth L Tighe, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Georgia State University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'centralContacts': [{'name': 'Rafaela G Feresin, PhD', 'role': 'CONTACT', 'email': 'berries@gsu.edu', 'phone': '404-413-1233'}], 'overallOfficials': [{'name': 'Rafaela G Feresin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgia State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgia State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wild Blueberry Association of North America', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Rafaela G. Feresin', 'investigatorAffiliation': 'Georgia State University'}}}}