Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT05031702
Status:
UNKNOWN
Last Update Posted:
2022-03-03
First Post:
2021-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Camelia Sinensis for Basal Metabolism and Body Composition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-07-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-15', 'studyFirstSubmitDate': '2021-08-27', 'studyFirstSubmitQcDate': '2021-08-27', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes on energy expenditure', 'timeFrame': 'Changes from baseline energy expenditure at 4 and at 8 weeks', 'description': 'Basal metabolic rate (Kcal/day)'}, {'measure': 'Changes on energy expenditure', 'timeFrame': 'Changes from baseline energy expenditure at 4 and at 8 weeks', 'description': '24 h urinary nitrogen (g/24 h)'}], 'secondaryOutcomes': [{'measure': 'Changes on body composition', 'timeFrame': 'Changes from baseline body composition at 4 and at 8 weeks', 'description': 'Fat Free Mass (g), Fat Mass (g), Visceral Adipose Tissue (g)'}, {'measure': 'Changes on anthropometry', 'timeFrame': 'Changes from baseline anthropometry at 4 and at 8 weeks', 'description': 'Weight (kg)'}, {'measure': 'Changes on anthropometry', 'timeFrame': 'Changes from baseline anthropometry at 4 and at 8 weeks', 'description': 'Body Mass Index (kg/m2)'}, {'measure': 'Changes on anthropometry', 'timeFrame': 'Changes from baseline anthropometry at 4 and at 8 weeks', 'description': 'Waist circumference (cm)'}, {'measure': 'Changes on insulin resistance', 'timeFrame': 'Changes from baseline insulin resistance at 4 and at 8 weeks', 'description': 'Homeostasis Model Assessment (pt) for evaluate insulin resistance if \\> 2,4'}, {'measure': 'Changes on carbohydrate profile', 'timeFrame': 'Changes from baseline carbohydrate profile at 4 and at 8 weeks', 'description': 'Glycemia (mg/dl)'}, {'measure': 'Changes on carbohydrate profile', 'timeFrame': 'Changes from baseline carbohydrate profile at 4 and at 8 weeks', 'description': 'Insulin (mcIU/ml)'}, {'measure': 'Changes on lipid profile', 'timeFrame': 'Changes from baseline lipid profile at 8 weeks', 'description': 'Total Cholesterol (mg/dl), High Density Lipoprotein Cholesterol (mg/dl), Low Density Lipoprotein Cholesterol (mg/dl), Tryglicerides (mg/dl)'}, {'measure': 'Changes on inflammation', 'timeFrame': 'Changes from baseline inflammation at 8 weeks', 'description': 'C-Reactive Protein (mg/dl)'}, {'measure': 'Changes on incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'Changes from baseline incidence of Treatment-Emergent Adverse Events at 8 weeks', 'description': 'Alanine Aminotrasferase (IU/l), Aspartate Aminotrasferase (IU/I)'}, {'measure': 'Changes on incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'Changes from baseline incidence of Treatment-Emergent Adverse Events at 8 weeks', 'description': 'Gamma Glutamyl Trasferase (U/l)'}, {'measure': 'Changes on citokine profile', 'timeFrame': 'Changes from baseline citokine profile at 4 and at 8 weeks', 'description': 'Adiponectin (microg/ml)'}, {'measure': 'Changes on citokine profile', 'timeFrame': 'Changes from baseline citokine profile at 4 and at 8 weeks', 'description': 'Leptin (ng/ml)'}, {'measure': 'Changes on plasma catecholamine profile', 'timeFrame': 'Changes from baseline plasma catecholamine profile at 4 and at 8 weeks', 'description': 'Adrenalin (ng/ml), Noradrenalin (ng/ml)'}, {'measure': 'Changes on satiety', 'timeFrame': 'Changes of satiety through 8 weeks', 'description': 'Haber test (pt) for evaluation of satiety from 0 (no satiety) to 10 (a lot of satiety)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postmenopausal Disorder']}, 'descriptionModule': {'briefSummary': 'Camellia Sinensis leaf extract contributes to increasing energy expenditure and calorie consumption by increasing thermogenesis. The purpose of this study is to evaluate the efficacy of Camellia Sinensis on basal metabolism and body composition in overweight women or with obesity in postmenopause.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopause\n* Overweight or obesity class I-II (Body Mass Index 25-39,9 Kg/m2)\n\nExclusion Criteria:\n\n* Changes in heart rhythm\n* Intolerance or allergy to components\n* Obesity class III (Body Mass Index \\> 40 Kg/m2)'}, 'identificationModule': {'nctId': 'NCT05031702', 'briefTitle': 'Camelia Sinensis for Basal Metabolism and Body Composition', 'organization': {'class': 'OTHER', 'fullName': 'Azienda di Servizi alla Persona di Pavia'}, 'officialTitle': 'Effectiveness of the Assumption of a Supplement Based on the Extract From Camelia Leaf Sinensis on Basal Metabolism and Body Composition in Overweight Women or With Obesity in Postmenopause', 'orgStudyIdInfo': {'id': '0905/14122018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dietary supplement', 'description': 'Extract from Camellia Sinensis leaf', 'interventionNames': ['Dietary Supplement: Camellia Sinensis leaf extract']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Tablets of the same size as the active component', 'interventionNames': ['Combination Product: Placebo']}], 'interventions': [{'name': 'Camellia Sinensis leaf extract', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 tablets per day of 150 mg (1 before lunch and 1 before dinner)', 'armGroupLabels': ['Dietary supplement']}, {'name': 'Placebo', 'type': 'COMBINATION_PRODUCT', 'description': '2 tablets per day of 150 mg (1 before lunch and 1 before dinner)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mariangela Rondanelli', 'role': 'CONTACT', 'email': 'mariangela.rondanelli@unipv.it', 'phone': '0382381739'}, {'name': 'Mariangela Rondanelli', 'role': 'CONTACT', 'email': 'mariangela.rondanelli@unipv.it', 'phone': '+390382381739', 'phoneExt': 'Rondanelli'}], 'facility': 'Mariangela Rondanelli', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda di Servizi alla Persona di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}