Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-01 @ 4:44 AM
Study NCT ID:
NCT01141803
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
2010-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Apple and Apple Pomace on Inflammation and Cholesterol Metabolism in Healthy Overweight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-19', 'studyFirstSubmitDate': '2010-06-08', 'studyFirstSubmitQcDate': '2010-06-10', 'lastUpdatePostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)', 'timeFrame': 'Measured at week 2'}, {'measure': 'Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)', 'timeFrame': 'Measured at week 6'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Measured at week 2'}, {'measure': 'Blood pressure', 'timeFrame': 'Measured at week 6'}, {'measure': 'Anthropometry (weight, height, waist and hip circumference)', 'timeFrame': 'Measured at week 2'}, {'measure': 'Anthropometry (weight, height, waist and hip circumference)', 'timeFrame': 'Measured at week 6'}, {'measure': 'Inflammatory marker (hs-CRP)', 'timeFrame': 'Measured at week 2'}, {'measure': 'Inflammatory marker (hs-CRP)', 'timeFrame': 'Measured at week 6'}, {'measure': 'Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)', 'timeFrame': 'Measured at week 2'}, {'measure': 'Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)', 'timeFrame': 'Measured at week 6'}, {'measure': 'Urine analyses (metabolomics)', 'timeFrame': 'Measured at week 2'}, {'measure': 'Urine analyses (metabolomics)', 'timeFrame': 'Measured at week 6'}, {'measure': 'Serum insulin, IGF-1 and IGFBP-3 levels', 'timeFrame': 'Measured at week 2'}, {'measure': 'Serum insulin, IGF-1 and IGFBP-3 levels', 'timeFrame': 'Measured at week 6'}, {'measure': 'Gene expression in white blood cells and colon tissue', 'timeFrame': 'Measured at week 2'}, {'measure': 'Gene expression in white blood cells and colon tissue', 'timeFrame': 'Measured at week 6'}, {'measure': 'Enzyme activity in lysed erythrocytes (glutathione peroxidase)', 'timeFrame': 'Measured at week 2'}, {'measure': 'Enzyme activity in lysed erythrocytes (glutathione peroxidase)', 'timeFrame': 'Measured at week 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Apple', 'Apple pomace', 'Metabolomics', 'Gene expression', 'Lipid metabolism', 'Prevention', 'Antiinflammatory effect'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The investigators will assess the protective and antiinflammatory effects of processed fruit and fruit fibre in overweight subjects with signs of metabolic syndrome. A single-blinded parallel study is conducted to investigate the protective effects of fruit fibre on colonic epithelium. Relevant signalling pathways related to cholesterol metabolism, vascular inflammation, oxidative defence, apoptosis and sterol metabolism will be targeted. Volunteers are randomly assigned one of three groups. They are instructed to follow a polyphenol and pectin restricted diet for six weeks. The last four weeks in this six week period, the restricted diet is supplemented with whole apples (550g/day), apple pomace (22g/day) or nothing. Blood, urine, faecal samples and colon biopsies are collected before and after the four weeks intervention period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* BMI over 30\n* No daily medication\n* Not strenuous exercise \\> 10hours/week\n* No blood donation 3 months before or during the study\n\nExclusion Criteria:\n\n* Smoking\n* Simultaneous participation in other research projects\n* Use of any dietary supplements'}, 'identificationModule': {'nctId': 'NCT01141803', 'briefTitle': 'Effect of Apple and Apple Pomace on Inflammation and Cholesterol Metabolism in Healthy Overweight', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Isafruit: Nutrigenomics in Overweight', 'orgStudyIdInfo': {'id': 'M198'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Apples', 'interventionNames': ['Dietary Supplement: Apples']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Apple pomace', 'interventionNames': ['Dietary Supplement: Apple pomace']}], 'interventions': [{'name': 'Apples', 'type': 'DIETARY_SUPPLEMENT', 'description': '550g of apples/day', 'armGroupLabels': ['Apples']}, {'name': 'Apple pomace', 'type': 'DIETARY_SUPPLEMENT', 'description': '22g apple pomace/day', 'armGroupLabels': ['Apple pomace']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1951', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Department of Human Nutrition, LIFE, University of Copenhagen', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Susanne Bügel, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Human Nutrition, LIFE, University of Copenhagen, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technical University of Denmark', 'class': 'OTHER'}, {'name': 'Central Jutland Regional Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Arne Astrup', 'investigatorAffiliation': 'University of Copenhagen'}}}}