Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-14 @ 2:27 PM
Study NCT ID:
NCT04616404
Status:
COMPLETED
Last Update Posted:
2020-11-05
First Post:
2020-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Metabolic Effects of Cynara Supplementation in Overweight and Obese Class I Subjects With Newly Detected Impaired Fasting Glycaemia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2020-10-13', 'studyFirstSubmitQcDate': '2020-10-29', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes on glycemia', 'timeFrame': 'Day 0, after 1 month and after 2 months'}], 'secondaryOutcomes': [{'measure': 'Changes on total cholesterol (mg/dl), HDL (mg/dl), total cholesterol/HLD, LDL (mg/dl), LDL/HDL, triglycerides (mg/dl), ApoA (mg/dl), ApoB (mg/dl), ApoB/ApoA, creatinine (mg/dl)', 'timeFrame': 'Day 0, after 1 month and after 2 months'}, {'measure': 'Changes on AST (UI/l), ALT (UI/l), GGT (U/l)', 'timeFrame': 'Day 0, after 1 month and after 2 months'}, {'measure': 'Changes on insulin (mcU/ml) and HOMA index', 'timeFrame': 'Day 0, after 1 month and after 2 months'}, {'measure': 'Changes on glycated hemoglobin (%)', 'timeFrame': 'Day 0, after 1 month and after 2 months'}, {'measure': 'Changes on A1c-Derived Average Glucose (mmol/l)', 'timeFrame': 'Day 0, after 1 month and after 2 months'}, {'measure': 'Changes on maximum blood pressure (mmHg), minimum blood pressure (mmHg)', 'timeFrame': 'Day 0, after 1 month'}, {'measure': 'Changes on waist circumference (cm)', 'timeFrame': 'Day 0, after 1 month'}, {'measure': 'Changes on VAT (g), lean and fat mass (g)', 'timeFrame': 'Day 0, after 1 month'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['impaired fasting glucose', 'Cynara cardunculus', 'Insulin Sensitivity', 'Obesity', 'Overweight'], 'conditions': ['Insulin Sensitivity', 'Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': 'Impaired fasting glucose (IFG) is a condition that precedes diabetes and increases the risk of developing it. Studies support the hypoglycemic effect of Cynara cardunculus (Cs) extracts due to the content of chlorogenic acid, which is a potent inhibitor of glucose 6-phosphate translocase and of dicaffeoylquinic acid derivatives that modulate the activity of alpha-glucosidase. Given this background, we investigated whether a new highly standardized Cs extract could improve glycaemic control, insulin sensitivity and other metabolic parameters (total, HDL and LDL cholesterol, Triglycerides, ApoB, ApoA, waist circumference, Visceral adipose tissue by DXA) in overweight subjects with newly diagnosed IFG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* without history of cardiovascular disease (CVD),\n* not taking any medication likely to affect glucose or lipid metabolism (oral hypoglycemic agents and statins)\n* free of overt liver, renal and thyroid disease\n\nExclusion Criteria:\n\n* smoking\n* drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)'}, 'identificationModule': {'nctId': 'NCT04616404', 'briefTitle': 'The Metabolic Effects of Cynara Supplementation in Overweight and Obese Class I Subjects With Newly Detected Impaired Fasting Glycaemia.', 'organization': {'class': 'OTHER', 'fullName': 'Azienda di Servizi alla Persona di Pavia'}, 'officialTitle': 'The Metabolic Effects of Cynara Supplementation in Overweight and Obese Class I Subjects With Newly Detected Impaired Fasting Glycaemia: a Double-blind, Placebo-controlled, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '9321/14122018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Group', 'interventionNames': ['Dietary Supplement: 500 mg of artichoke extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': '500 mg of artichoke extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Tablets containing 500 mg of artichoke extract (triple standardized to contain caffeoylquinic acids ≥ 5.0%; flavonoids ≥ 1.5%; cynaropicrin ≥ 1.0%, by HPLC)', 'armGroupLabels': ['Intervention Group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Tablets with no active ingredient', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'state': 'PV', 'country': 'Italy', 'facility': "Azienda di Servizi alla Persona ''Istituto Santa Margherita''", 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda di Servizi alla Persona di Pavia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Indena S.p.A', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}