Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2026-03-07 @ 2:37 PM
Study NCT ID:
NCT02245906
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2014-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Brazilian Fruits Peel on Metabolic Regulation and Appetite in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-06', 'studyFirstSubmitDate': '2014-09-16', 'studyFirstSubmitQcDate': '2014-09-19', 'lastUpdatePostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changing on blood glucose concentration after treatment with brazilian fruits peel', 'timeFrame': 'Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min', 'description': 'The capillary blood samples will be taken for blood glucose analysis'}], 'secondaryOutcomes': [{'measure': 'Changing on subjective appetite ratings after treatment with Brazilian fruits peel', 'timeFrame': 'Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.', 'description': 'Appetite will be assessed using standard subjective 100 mm VAS (visual analogue scale) at time intervals throughout each visit'}, {'measure': 'Identify plasma metabolite profile (untargeted approach) after treatment with Brazilian fruits peel', 'timeFrame': 'Prior to the initial intervention at 0 min and after intervention at 60, 90, 120, 180 min.', 'description': 'Metabolite profile will be analyzed using Liquid Chromatography-Mass Spectrometry based methods'}, {'measure': 'Changing on insulin after treatment with Brazilian fruits peel', 'timeFrame': 'Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.', 'description': 'The venous serum blood samples will be taken for insulin analysis'}, {'measure': 'Changing on inflammatory markers (i.e. interleukin-6, interleukin-8, tumor necrosis factor-alpha, necrosis factor kappa-beta, adiponectin and C-reactive protein) after treatment with Brazilian fruits peel', 'timeFrame': 'Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.', 'description': 'The venous serum blood samples will be taken for inflammatory markers analysis'}, {'measure': 'Changing on appetite markers (i.e. ghrelin, cholecystokinin, glucagon-like peptide-1, gastric inhibitory polypeptide, peptide YY, amylin, pancreatic polypeptide) after treatment with Brazilian fruits peel', 'timeFrame': 'Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.', 'description': 'The venous serum blood samples will be taken for appetite markers analysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Brazilian fruit peel', 'Functional food', 'Cardiometabolic risk', 'Metabolic syndrome', 'Inflammation', 'Appetite', 'Gut hormone'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to investigate how Brazilian fruits peel affect acute/postprandial glucose and insulin responses, inflammatory markers, appetite control peptides, antioxidative capacity, as well as subjective appetite ratings (VAS-visual analogue scales) in healthy volunteers. We hypothesize that certain Brazilian fruits peel added to a standardized meal will improve postprandial glucose tolerance and other metabolic biomarkers in healthy volunteers, compared with a similar meal without the corresponding plant materials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females\n* Signed informed consent\n* BMI 20 - 28 kg/m2 with weight change \\<3 kg latest 2 months\n* Must be able to accept plant-based foods/drinks\n\nExclusion Criteria:\n\n* Below 18 years\n* Uncomfortable speaking English and/or difficulties in understanding spoken English\n* Smoking or using snuff\n* Vegetarian or vegan\n* Stressed by venous blood sampling or previous experience of being difficult to cannulate\n* Receiving any drug treatment that may influence the study outcomes\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT02245906', 'acronym': 'BRASIL-MET', 'briefTitle': 'Effect of Brazilian Fruits Peel on Metabolic Regulation and Appetite in Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Investigation on Effect of Brazilian Fruits on Glucose and Insulin Responses, Anti-inflammatory Properties, Antioxidative Capacity and Satiety in Healthy Subjects', 'orgStudyIdInfo': {'id': 'BRASIL-MET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control drink', 'description': '300 ml control drink containing equal amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration', 'interventionNames': ['Dietary Supplement: Control drink']}, {'type': 'EXPERIMENTAL', 'label': 'Brazilian fruit peel', 'description': '300 ml test drink containing Brazilian fruit peel flour, acute study / one time administration', 'interventionNames': ['Dietary Supplement: Brazilian fruit peel flour']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Negative control drink', 'description': '300 ml control drink without containing amount of total fiber and pectine as Brazilian fruit drink, acute study / one time administration', 'interventionNames': ['Dietary Supplement: Negative control drink']}], 'interventions': [{'name': 'Control drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'As a control, subjects are asked to consume 300 ml control drinks containing equal amount of total fiber and pectine as Brazilian fruit drink. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.', 'armGroupLabels': ['Control drink']}, {'name': 'Brazilian fruit peel flour', 'type': 'DIETARY_SUPPLEMENT', 'description': 'In this study, subjects are asked to consume 300 ml beverage drinks contain certain amounts of Brazilian fruit peel flour. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.', 'armGroupLabels': ['Brazilian fruit peel']}, {'name': 'Negative control drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'As a negative control, subjects are asked to consume 300 ml control drinks without containing amount of total fiber and pectine as Brazilian fruit drink. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.', 'armGroupLabels': ['Negative control drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221 00', 'city': 'Lund', 'state': 'Skåne County', 'country': 'Sweden', 'facility': 'Antidiabetic Food Centre (Medicon Village) - Lund University', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Elin Östman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}, {'name': 'Glaucia Lima, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Lund University'}, {'name': 'Yoghatama Cindya Zanzer, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Lund University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Campinas, Brazil', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof, PhD', 'investigatorFullName': 'Elin Östman', 'investigatorAffiliation': 'Lund University'}}}}