Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 9:39 PM
Study NCT ID:
NCT06230861
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2024-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Quercetin on Cardiometabolic Outcomes
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011794', 'term': 'Quercetin'}], 'ancestors': [{'id': 'D044948', 'term': 'Flavonols'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2024-01-19', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': 'Baseline', 'description': 'Systolic blood pressure - measured using a digital blood pressure monitor'}, {'measure': 'Systolic blood pressure', 'timeFrame': '20 days', 'description': 'Systolic blood pressure - measured using a digital blood pressure monitor'}], 'secondaryOutcomes': [{'measure': 'Diastolic blood pressure', 'timeFrame': 'Baseline', 'description': 'Diastolic blood pressure - measured using a digital blood pressure monitor'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '20 days', 'description': 'Diastolic blood pressure - measured using a digital blood pressure monitor'}, {'measure': 'Percent bodyfat', 'timeFrame': 'Baseline', 'description': 'Participants percentage composition of fat - measured using bio-electrical impedance'}, {'measure': 'Percent bodyfat', 'timeFrame': '20 days', 'description': 'Participants percentage composition of fat - measured using bio-electrical impedance'}, {'measure': 'Waist to hip ratio', 'timeFrame': 'Baseline', 'description': 'Ratio of waist to hip circumference - measured using anthropocentric tape'}, {'measure': 'Waist to hip ratio', 'timeFrame': '20 days', 'description': 'Ratio of waist to hip circumference - measured using anthropocentric tape'}, {'measure': 'Blood glucose', 'timeFrame': 'Baseline', 'description': 'Capillary blood glucose - mmol/L'}, {'measure': 'Blood glucose', 'timeFrame': '20 days', 'description': 'Capillary blood glucose - mmol/L'}, {'measure': 'Blood triglycerides', 'timeFrame': 'Baseline', 'description': 'Capillary blood triglycerides - mmol/L'}, {'measure': 'Blood triglycerides', 'timeFrame': '20 days', 'description': 'Capillary blood triglycerides - mmol/L'}, {'measure': 'Triglyceride glucose index', 'timeFrame': 'Baseline', 'description': 'Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)'}, {'measure': 'Triglyceride glucose index', 'timeFrame': '20 days', 'description': 'Calculated as the natural logarithm of (blood triglycerides x blood glucose) /2)'}, {'measure': 'Blood cholesterol (Total, HDL & LDL)', 'timeFrame': 'Baseline', 'description': 'Capillary blood cholesterol - mmol/L'}, {'measure': 'Blood cholesterol (Total, HDL & LDL)', 'timeFrame': '20 days', 'description': 'Capillary blood cholesterol - mmol/L'}, {'measure': 'Coop-Wonka chart', 'timeFrame': 'Baseline', 'description': 'Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring'}, {'measure': 'Coop-Wonka chart', 'timeFrame': '20 days', 'description': 'Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring'}, {'measure': 'Beck Depression Inventory', 'timeFrame': 'Baseline', 'description': 'Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.'}, {'measure': 'Beck Depression Inventory', 'timeFrame': '20 days', 'description': 'Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.'}, {'measure': 'State Trait Anxiety Inventory', 'timeFrame': 'Baseline', 'description': 'Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.'}, {'measure': 'State Trait Anxiety Inventory', 'timeFrame': '20 days', 'description': 'Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.'}, {'measure': 'Insomnia Severity Index', 'timeFrame': 'Baseline', 'description': 'Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.'}, {'measure': 'Insomnia Severity Index', 'timeFrame': '20 days', 'description': 'Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'Baseline', 'description': 'Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '20 days', 'description': 'Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.'}, {'measure': 'Epworth Sleepiness Scale', 'timeFrame': 'Baseline', 'description': 'Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.'}, {'measure': 'Epworth Sleepiness Scale', 'timeFrame': '20 days', 'description': 'Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiometabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. It has been postulated that Quercetin may be beneficial in improving cardiometabolic outcomes. However, to date, no research has explored this using a placebo randomized intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Between 18 \\& 65 years\n* Non-smoker\n* BMI \\< 30\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Diabetes or any other metabolic/ uncontrolled hypertensive conditions\n* Food allergies to quercetin\n* Habitual consumption of quercetin\n* Not regularly taking medication or antioxidant supplements'}, 'identificationModule': {'nctId': 'NCT06230861', 'briefTitle': 'Effects of Quercetin on Cardiometabolic Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Central Lancashire'}, 'officialTitle': 'Effects of Quercetin Supplementation on Cardiometabolic Parameters', 'orgStudyIdInfo': {'id': 'Quercetin cardiometabolic'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quercetin tablets 400mg 1 x p/d', 'description': 'Quercetin tablets 400mg 1 x p/d', 'interventionNames': ['Dietary Supplement: Quercetin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Quercetin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Quercetin tablets 500mg 1 x per day', 'armGroupLabels': ['Quercetin tablets 400mg 1 x p/d']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo control 1 x blinded placebo tablet per day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PR4 0PE', 'city': 'Preston', 'state': 'Lancashire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Jonathan Sinclair, DSc, PhD', 'role': 'CONTACT', 'email': 'jksinclair@uclan.ac.uk', 'phone': '07875651533'}], 'facility': 'University of Central Lancashire', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}], 'centralContacts': [{'name': 'Jonathan Sinclair, PhD, DSc', 'role': 'CONTACT', 'email': 'jksinclair@uclan.ac.uk', 'phone': '+447875651533'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Central Lancashire', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jonathan Sinclair', 'investigatorAffiliation': 'University of Central Lancashire'}}}}