Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-31 @ 5:47 AM
Study NCT ID:
NCT02035592
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2014-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Health Effects of Blueberry Anthocyanins in Metabolic Syndrome (the CIRCLES-study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-28', 'studyFirstSubmitDate': '2014-01-10', 'studyFirstSubmitQcDate': '2014-01-10', 'lastUpdatePostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin resistance', 'timeFrame': 'Chronic (0 to 6 month)', 'description': 'Assessed, in the fasted state, via HOMA-IR calculation in all participants; indirect assessment.'}], 'secondaryOutcomes': [{'measure': 'Insulin resistance', 'timeFrame': 'Chronic (0 to 6 month)', 'description': 'Assessed in a sub-group via hyperinsulinemic euglycaemic clamp.'}, {'measure': 'Blood pressure and blood vessel regulation', 'timeFrame': 'Chronic (0 to 6 month)', 'description': 'Measurements taken of arterial stiffness, endothelial function and blood pressure.'}, {'measure': 'Lung function', 'timeFrame': 'Chronic (0 to 6 month)', 'description': 'Assessed via standard spirometry techniques and biological assessment of exhaled samples.'}, {'measure': 'Cognitive function', 'timeFrame': 'Chronic (0 to 6 month)', 'description': 'Assessed via a validated cognitive test battery.'}, {'measure': 'Liver fat and blood flow assessment', 'timeFrame': 'Chronic (0 to 6 month)', 'description': 'Assessment via 3T MRI in a sub-group of participants.'}, {'measure': 'Bio-availability', 'timeFrame': 'Chronic (0 to 6 month)', 'description': 'Flavonoid and metabolite levels will be assessed in blood and 24 hour urine samples.'}, {'measure': 'Metabolite phenotype effects', 'timeFrame': 'Chronic (0 to 6 month)', 'description': 'The gut microbiome will be assessed from faecal sample collection and the impact on metabolism and of genotype, will be assessed via a targeted approach.'}, {'measure': 'Acute +24 hour effect of single (26g) intervention intake, given with high fat challenge', 'timeFrame': 'Chronic (0 to 6 month)', 'description': 'Insulin resistance, lipaemia, vascular, cognitive and lung function measured pre- and post-intervention in combination with a high fat challenge in a sub-group of participants. Urine samples and blood samples (over a 24 hour period) will be taken for biomarker analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Insulin Resistance', 'Metabolic Syndrome X']}, 'referencesModule': {'references': [{'pmid': '38432713', 'type': 'DERIVED', 'citation': 'Curtis PJ, van der Velpen V, Berends L, Jennings A, Haag L, Minihane AM, Chandra P, Kay CD, Rimm EB, Cassidy A. Chronic and postprandial effect of blueberries on cognitive function, alertness, and mood in participants with metabolic syndrome - results from a six-month, double-blind, randomized controlled trial. Am J Clin Nutr. 2024 Mar;119(3):658-668. doi: 10.1016/j.ajcnut.2023.12.006. Epub 2024 Feb 6.'}, {'pmid': '34883305', 'type': 'DERIVED', 'citation': 'Curtis PJ, Berends L, van der Velpen V, Jennings A, Haag L, Chandra P, Kay CD, Rimm EB, Cassidy A. Blueberry anthocyanin intake attenuates the postprandial cardiometabolic effect of an energy-dense food challenge: Results from a double blind, randomized controlled trial in metabolic syndrome participants. Clin Nutr. 2022 Jan;41(1):165-176. doi: 10.1016/j.clnu.2021.11.030. Epub 2021 Nov 27.'}, {'pmid': '31136659', 'type': 'DERIVED', 'citation': 'Curtis PJ, van der Velpen V, Berends L, Jennings A, Feelisch M, Umpleby AM, Evans M, Fernandez BO, Meiss MS, Minnion M, Potter J, Minihane AM, Kay CD, Rimm EB, Cassidy A. Blueberries improve biomarkers of cardiometabolic function in participants with metabolic syndrome-results from a 6-month, double-blind, randomized controlled trial. Am J Clin Nutr. 2019 Jun 1;109(6):1535-1545. doi: 10.1093/ajcn/nqy380.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the dose-dependent impact of 6 month freeze-dried blueberry powder intake on insulin sensitivity and resistance, cardiovascular disease risk factors, and lung and cognitive function in overweight and obese participants with metabolic syndrome. We will also examine acute post-prandial effects of blueberry intake (at baseline and at 6-months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and postmenopausal women (≥ 1 year since last menstruation)\n* 50 to 75 years old\n* BMI of ≥ 25 kg/m2\n* 3 characteristics of metabolic syndrome i.e: Waist circumference ≥ 102 cm for men, ≥ 88 cm for women; Triglycerides ≥ 1.7 mmol/L (or drug treatment for elevated triglycerides); HDL-cholesterol \\< 1.0 mmol/L for men, \\< 1.3 mmol/L for women (or drug treatment for low HDL-cholesterol); Blood pressure ≥ 130 mm Hg systolic and/or ≥ 85 mm Hg diastolic blood pressure; Fasting blood glucose ≥ 5.56 mmol/L\n* Successful biochemical, haematological and urinalysis assessment at screening\n\nExclusion Criteria:\n\n* Current smokers, or ex-smokers ceasing \\< 6 months ago\n* Existing or significant past medical history of vascular disease or medical conditions likely to affect the study measures\n* Fructose intolerance or known allergies to the intervention treatments\n* On therapeutic diets or having experienced substantial weight loss within 3 months of screening\n* Taking flavonoid containing supplements (and unwilling to cease intake during, and 1 month preceding the trial)\n* Planning on altering consumption of vitamin supplements / fish oil capsules during the course of the study.\n* Prescribed hypoglycaemic, vasodilators or HRT medication.\n* Unsatisfactory biochemical, haematological or urinary assessment at screening, or measures considered to be counter indicative for the study\n* \\< 3 characteristics of the metabolic syndrome.\n\nNB: REC approved NoSA granted to include those on anti-hypertensives (29JUL2014)'}, 'identificationModule': {'nctId': 'NCT02035592', 'acronym': 'CIRCLES', 'briefTitle': 'The Health Effects of Blueberry Anthocyanins in Metabolic Syndrome (the CIRCLES-study)', 'organization': {'class': 'OTHER', 'fullName': 'University of East Anglia'}, 'officialTitle': 'The Effects of Blueberry Anthocyanins on Insulin Resistance and Vascular, Lung and Cognitive Function in a Population With Metabolic Syndrome.', 'orgStudyIdInfo': {'id': 'R21478-C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Full dose blueberry', 'description': '26g of freeze dried blueberry powder; equivalent to 2 portions of fresh blueberries per day.\n\nFrequency: 26g per day.\n\nTotal duration: 6-month.', 'interventionNames': ['Other: Full dose blueberry']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Half dose blueberry', 'description': '26g of freeze dried powder; containing 13g of freeze dried blueberry powder and 13g of placebo comparator material; equivalent to 1 portion of fresh blueberries per day.\n\nFrequency: 26g per day.\n\nTotal duration: 6-month.', 'interventionNames': ['Other: Half dose blueberry']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Matched control powder; matched for appearance, taste and sugar content.\n\nFrequency: 26g per day.\n\nTotal duration: 6-month.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Full dose blueberry', 'type': 'OTHER', 'description': 'Full dose: 26g of freeze dried blueberry powder to be incorporated into the habitual diet.\n\nDietary restrictions will be observed (i.e. avoidance of blueberry, and restricted intake of anthocyanin rich foods) for 21 days prior to the first assessment visit and throughout the study.', 'armGroupLabels': ['Full dose blueberry']}, {'name': 'Half dose blueberry', 'type': 'OTHER', 'description': 'Half dose: 26g of freeze dried powder (containing 13g of freeze dried blueberry powder and 13g of placebo comparator material) to be incorporated into the habitual diet.\n\nDietary restrictions will be observed (i.e. avoidance of blueberry, and restricted intake of anthocyanin rich foods) for 21 days prior to the first assessment visit and throughout the study.', 'armGroupLabels': ['Half dose blueberry']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Control: 26g of placebo comparator material to be incorporated into the habitual diet.\n\nDietary restrictions will be observed (i.e. avoidance of blueberry, and restricted intake of anthocyanin rich foods) for 21 days prior to the first assessment visit and throughout the study.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard School of Public Health', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': "Addenbrooke's hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'NR4 7TJ', 'city': 'Norwich', 'state': 'Norfolk', 'country': 'United Kingdom', 'facility': 'Norwich Medical School University of East Anglia', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'zip': 'NR4 7UY', 'city': 'Norwich', 'state': 'Norfolk', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospital', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}], 'overallOfficials': [{'name': 'Aedin Cassidy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of East Anglia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of East Anglia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}