Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT05022732
Status:
COMPLETED
Last Update Posted:
2021-08-26
First Post:
2021-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Polyglucosamine L112 in Overweight and Obese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-20', 'studyFirstSubmitDate': '2021-08-20', 'studyFirstSubmitQcDate': '2021-08-20', 'lastUpdatePostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes on anthropometric measures', 'timeFrame': 'Changes from baseline anthropometric measures at 90 days', 'description': 'Body weight (Kg)'}], 'secondaryOutcomes': [{'measure': 'Changes on lipid profile', 'timeFrame': 'Changes from baseline lipid profile at 90 days', 'description': 'Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Triglycerides (mg/dl)'}, {'measure': 'Changes on insulin resistance', 'timeFrame': 'Changes from baseline insulin resistance at 90 days', 'description': 'Homeostasis Model Assessment (pt) for evaluate insulin resistance il \\> 2,4'}, {'measure': 'Changes on Carbohydrate profile', 'timeFrame': 'Changes from baseline Carbohydrate profile at 90 days', 'description': 'Glycemia (mg/dl)'}, {'measure': 'Changes on Carbohydrate profile', 'timeFrame': 'Changes from baseline Carbohydrate profile at 90 days', 'description': 'Insulin (mcU/ml)'}, {'measure': 'Changes on safety', 'timeFrame': 'Changes from baseline safety at 90 days', 'description': 'Aspartate aminotransferase (IU/l), alanine aminotransferase (IU/l)'}, {'measure': 'Changes on safety', 'timeFrame': 'Changes from baseline safety at 90 days', 'description': 'Gamma glutamyl transferase (U/I)'}, {'measure': 'Changes on safety', 'timeFrame': 'Changes from baseline safety at 90 days', 'description': 'Creatinine (mg/dl)'}, {'measure': 'Changes on anthropometric measures', 'timeFrame': 'Changes from baseline anthropometric measures at 90 days', 'description': 'Waist circumference (cm)'}, {'measure': 'Changes on anthropometric measures', 'timeFrame': 'Changes from baseline anthropometric measures at 90 days', 'description': 'Body Mass Index (Kg/m2)'}, {'measure': 'Changes on body composition', 'timeFrame': 'Changes from baseline body composition at 90 days', 'description': 'Free Fat Mass (g), Fat Mass (g), Visceral Adipose Tissue (g)'}, {'measure': 'Changes on oxidative stress', 'timeFrame': 'Changes from baseline oxidative stress at 90 days', 'description': 'Reactive Oxygen Species (CARR U)'}, {'measure': 'Changes on oxidative stress', 'timeFrame': 'Changes from baseline oxidative stress at 90 days', 'description': 'Total Antioxidant Capacity (ORAC U)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Polyglucosamine', 'Body composition', 'Inflammation'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This research proposes as its main purpose to evaluate the effectiveness of the intake of Polyglucosamine at a dose of 3 g / day on weight loss in a group of subjects suffering from overweight and mild obesity (BMI between 25 and 32 kg / m2). and with weight\\> 75 kg'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* weight \\> 75 Kg\n* absence of previous diet therapy attempts\n* no fluctuation of at least 3 kg in the previous 3 months\n* Beck Depression Inventory score \\< 20 pt\n* Binge Eating Scale score \\< 27 pt\n\nExclusion Criteria:\n\n* allergy to shellfish\n* pregnancy or breast feeding\n* presence of cardiopathies, nephropathies, liver diseases, bronchopneumopathies, haemopathies, dermopathies, chronic-degenerative diseases of the Central Nervous System\n* presence of active peptic ulcer, ulcerative colitis, Crohn's disease, celiac disease, inflammatory bowel disease\n* symptomatic cholelithiasis\n* previous or current neoplasms\n* epilepsy\n* obesity secondary to endocrinopathies or genetic syndromes\n* significant motor disability or mental retardation\n* major depressive disorder, bulimia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar disorder (I or II), schizophrenia\n* previous history or current diagnosis of drug abuse or alcoholism\n* changing in smoking habits or quitting smoking in the last 6 months\n* current use or in the last 3 months of psychoactive drugs or current use or in the last 12 months of drugs affecting body weight or appetite"}, 'identificationModule': {'nctId': 'NCT05022732', 'briefTitle': 'Polyglucosamine L112 in Overweight and Obese Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Azienda di Servizi alla Persona di Pavia'}, 'officialTitle': 'Double-blind, Randomized, Placebo-controlled Clinical Study to Evaluate the Effect on Weight of a Medical Device Based on Polyglucosamine L112® in a Group of Overweight and Obese Subjects', 'orgStudyIdInfo': {'id': '20200037586'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control formula', 'description': 'Excipients and gum arabic in tablet', 'interventionNames': ['Combination Product: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental formula', 'description': 'Polyglucosamine L112 (750 mg of chitosan for tablet formulated with ascorbic acid and tartaric acids in the relative proportions of 91-6-3% with the addition of formulating excipients)', 'interventionNames': ['Dietary Supplement: Polyglucosamine L112']}], 'interventions': [{'name': 'Polyglucosamine L112', 'type': 'DIETARY_SUPPLEMENT', 'description': '750 mg of chitosan for tablet formulated with ascorbic acid and tartaric acids in the relative proportions of 91-6-3% with the addition of formulating excipients', 'armGroupLabels': ['Experimental formula']}, {'name': 'Placebo', 'type': 'COMBINATION_PRODUCT', 'description': 'excipients and gum arabic', 'armGroupLabels': ['Control formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Azienda di Servizi alla Persona', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Mariangela Rondanelli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Casemiro Mondino'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda di Servizi alla Persona di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}