Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT07263802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018149', 'term': 'Glucose Intolerance'}, {'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-23', 'studyFirstSubmitDate': '2025-11-23', 'studyFirstSubmitQcDate': '2025-11-23', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects on glycemia', 'timeFrame': '90 days', 'description': 'evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.'}], 'secondaryOutcomes': [{'measure': 'Change in Insulin sensitivity', 'timeFrame': '90 days', 'description': 'The secondary objective will be to evaluate the efficacy of GlycoDual in reducing insulin sensitivity (HOMA-IR) levels compared to placebo after 90 days of treatment.'}, {'measure': 'Change in uricemia', 'timeFrame': '90 days', 'description': 'The secondary objective will be to evaluate the efficacy of GlycoDual in reducing uricemia levels compared to placebo after 90 days of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dysglycemia', 'Gymnema sylvestre', 'Zinc bisglycinate'], 'conditions': ['Impaired Fasting Glucose (IFG)', 'Impaired Glucose Tolerance (Prediabetes)']}, 'descriptionModule': {'briefSummary': 'The primary objective will be to evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.\n\nSecondary objectives are to estimate:\n\n* the change of insulin sensitivity (HOMA-IR)\n* the change of uricemia after 90 days of supplementation compared to placebo.\n\nSafety objectives: Collection of the adverse events not related, related or possibly related to the study products.', 'detailedDescription': 'Mild dysglycemias, such as impaired fasting glucose (IFG) and impaired glucose tolerance (IGT), represent pre-diabetic conditions characterized by a subclinical impairment of insulin sensitivity and β-cell function. Early intervention in this phase can prevent or delay the progression to full-blown diabetes. In this context, the use of nutraceutical supplements with physiological activity on glucose metabolism represents a promising and well-tolerated approach, able to effectively modulate metabolic parameters, with a good safety profile. GlycoDual is a food supplement developed to control post-prandial glycemia and improve insulin sensitivity in subjects with impaired glucose metabolism. GlycoDual contains maqui berry, blueberry, cocoa (rich in anthocyanins and epicatechin), and chromium picolinate, aimed at modulating the immediate glycemic response through the inhibition of α-glucosidase, stimulation of glucose transport and insulin sensitization. It also contains Gymnema sylvestre and zinc bisglycinate, aimed at supporting insulin secretion and contributing to the long-term regulation of glycemia The primary objective will be to evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.\n\nSecondary objectives are to estimate:\n\n* the change of insulin sensitivity (HOMA-IR)\n* the change of uricemia after 90 days of supplementation compared to placebo.\n\nSafety objectives: Collection of the adverse events not related, related or possibly related to the study products.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body mass index (BMI) 25.0-29.9 kg/m2\n* FPG levels between 100 and 125 mg/dl \\[IFG diagnosed after Oral Glucose Tolerance Test (OGTT)\\]\n* HOMA-IR \\> 2.5\n* subjects able to understand the informed consent and sign it before enrollment in the study\n\nExclusion Criteria:\n\n* personal history of cardiovascular disease or equivalent risk factors\n* obesity (BMI ≥ 30 kg/m²)\n* taking hypoglycemic drugs or supplements that affect glycemic metabolism\n* diabetes mellitus or IGT\n* pregnancy or breastfeeding\n* known thyroid, liver, kidney or muscle diseases\n* any medical or surgical condition that makes patient compliance with the study protocol complex or inconsistent\n* any known allergy or hypersensitivity to one or more components of the food supplement'}, 'identificationModule': {'nctId': 'NCT07263802', 'briefTitle': 'Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'Evaluation of the Efficacy of GlycoDual on Postprandial Glycemic Control and Insulin Sensitivity in Subjects With Impaired Glucose Metabolism: a Randomized, Controlled, Double-blind Study', 'orgStudyIdInfo': {'id': 'GDUAL-2025-RCT01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Patients taking nutraceutical', 'interventionNames': ['Dietary Supplement: GlycoDual']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients taking placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'GlycoDual', 'type': 'DIETARY_SUPPLEMENT', 'description': 'GlycoDual is a food supplement developed to control post-prandial glycemia and improve insulin sensitivity in subjects with impaired glucose metabolism. GlycoDual contains maqui berry, blueberry, cocoa (rich in anthocyanins and epicatechin), and chromium picolinate, aimed at modulating the immediate glycemic response through the inhibition of α-glucosidase, stimulation of glucose transport and insulin sensitization. It also contains Gymnema sylvestre and zinc bisglycinate, aimed at supporting insulin secretion and contributing to the long-term regulation of glycemia', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Giuseppe Derosa, MD', 'role': 'CONTACT', 'email': 'g.derosa@smatteo.pv.it', 'phone': '+390382502614'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Giuseppe Derosa', 'investigatorFullName': 'Giuseppe Derosa', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}