Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-02-20 @ 6:21 PM
Study NCT ID:
NCT04161859
Status:
COMPLETED
Last Update Posted:
2022-05-24
First Post:
2019-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Nutraceuticals in Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 387}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-21', 'studyFirstSubmitDate': '2019-11-10', 'studyFirstSubmitQcDate': '2019-11-10', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of the use of nutraceutical in clinical practice', 'timeFrame': 'From 2010 to 2015', 'description': 'Prevalence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyslipidemias', 'Diabetes Mellitus, Type 2', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended in the clinic. In particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages.', 'detailedDescription': 'The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended in the clinic. In particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages. In particular, attention will be focused on the following substances: berberine (500-1000 mg/day), monacolin (5-10 mg/day), phytosterols (0.9-1.8 g/day), resveratrol (100-500 mg/day), omega-3 (1-3 g/day), alpha lipoic acid (400-800 mg/day), curcumin (400 mg/day), psyllum (3.5 g/day), coenzyme Q10 (100-200 mg/day), inositol (250-600 mg/day), glucomannan (1-4 g/day), chitosan (800-1200 mg/day), guar fiber (10-20 g/day), L-arginine (250 mg/day).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic, or hypertensive or dyslipidemic patients in primary and secondary prevention', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiabetic patients in primary and secondary prevention or Hypertensive patients in primary and secondary prevention or Dyslipidemic patients in primary and secondary prevention\n\nExclusion Criteria:\n\nPatients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.'}, 'identificationModule': {'nctId': 'NCT04161859', 'briefTitle': 'Use of Nutraceuticals in Clinical Practice', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'Observational Study on the Use of the Nutraceutical With Cardio-metabolic Actions in the Patient in Primary and Secondary Prevention', 'orgStudyIdInfo': {'id': 'P-20160020534'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nutraceutical', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Nutraceutical with action on glycemia, dsylipidemia or hypertension will be considered.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Giuseppe Derosa', 'investigatorAffiliation': 'University of Pavia'}}}}