Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-27 @ 1:08 AM
Study NCT ID:
NCT02479334
Status:
COMPLETED
Last Update Posted:
2015-09-22
First Post:
2015-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of 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': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-19', 'studyFirstSubmitDate': '2015-03-30', 'studyFirstSubmitQcDate': '2015-06-19', 'lastUpdatePostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 2 hr and 4 hr', 'timeFrame': 'Prior to the initial intervention at 0 hr and after intervention at 2 hr and 4 hr.', 'description': 'The venous blood samples will be taken for isolation of peripheral blood mononuclear cells. Extracted total RNA will then be used for running RNA-seq/whole-transcriptome shotgun sequencing (Illumina, San Diego, CA, USA)'}], 'secondaryOutcomes': [{'measure': 'Subjective appetite ratings using standard subjective 100 mm VAS', 'timeFrame': 'Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.', 'description': 'Appetite will be assessed using standard subjective 100 mm VAS (visual analogue scale) at time intervals throughout each visit'}, {'measure': 'Metabolic biomarkers', 'timeFrame': 'Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.', 'description': 'The capillary blood samples will be taken for blood glucose analysis. The venous blood samples will be taken for further assessment of insulin, triacylglycerol, NEFA and inflammatory biomarkers (i.e. IL-6, IL-8, CRP)'}, {'measure': 'Metabolite profile', 'timeFrame': 'Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.', 'description': 'Metabolite profile will be analyzed using Liquid Chromatography-Mass Spectrometry based methods'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Spices', 'Functional food', 'Cardiometabolic risk', 'Metabolic syndrome', 'Inflammation', 'Peripheral blood mononuclear cell', 'Acute'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the effect of spices on gene expression of pathways associated with glucose homeostasis, oxidative stress and inflammation, in the postprandial phase in healthy human subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females\n* BMI 20-28 kg/m2\n* Must be able to accept spices\n* Agreed and signed informed consent\n\nExclusion Criteria:\n\n* Below 18 years old\n* Uncomfortable speaking English and/or difficulties in understanding spoken English\n* Smoking or using snuss\n* Vegetarian or vegan\n* Stressed by venous blood sampling or previous experience of being difficult to be cannulated\n* Receiving any drug treatment that may influence the study outcomes\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT02479334', 'briefTitle': 'Acute Effects of Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Acute Effects of Spices on Pathways Associated With Glucose Homeostasis, Oxidative Stress and Inflammation in Healthy Subjects - Molecular Insights Through Transcriptomics of Peripheral Blood Mononuclear Cells (PBMC)', 'orgStudyIdInfo': {'id': 'LUND-AFC-STAGE3-SPICENUTROMICS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Fat challenge breakfast', 'description': '200 ml control drink (non-energy flavored water) and high fat breakfast (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration', 'interventionNames': ['Other: Fat challenge breakfast']}, {'type': 'EXPERIMENTAL', 'label': 'Fat challenge breakfast+spices', 'description': '200 ml spices drink (non-energy flavored water + spices extract) and high fat breakfast (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration', 'interventionNames': ['Other: Fat challenge breakfast+spices']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Carbohydrate challenge breakfast', 'description': '200 ml control drink (non-energy flavored water) and high carbohydrate breakfast (% Energy Carbohydrate:Fat:Prot / 60:20:20), acute study / one time administration', 'interventionNames': ['Other: Carbohydrate challenge breakfast']}, {'type': 'EXPERIMENTAL', 'label': 'Carbohydrate challenge breakfast+spices', 'description': '200 ml spices drink (non-energy flavored water + spices extract) and high carbohydrate breakfast (% Energy Carbohydrate:Fat:Prot / 60:20:20), acute study / one time administration', 'interventionNames': ['Other: Carbohydrate challenge breakfast+spices']}], 'interventions': [{'name': 'Fat challenge breakfast', 'type': 'OTHER', 'description': 'In this intervention, subjects are asked to consume 200 ml control drinks (non-energy flavored water). Following 10 min. beverage consumption, subjects will be given standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20', 'armGroupLabels': ['Fat challenge breakfast']}, {'name': 'Fat challenge breakfast+spices', 'type': 'OTHER', 'description': 'In this intervention, subjects are asked to consume 200 ml spices drinks (non-energy flavored water + spices extract). Following 10 min. beverage consumption, subjects will be given standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20', 'armGroupLabels': ['Fat challenge breakfast+spices']}, {'name': 'Carbohydrate challenge breakfast', 'type': 'OTHER', 'description': 'In this intervention, subjects are asked to consume 200 ml control drinks (non-energy flavored water). Following 10 min. beverage consumption, subjects will be given standardized high carbohydrate breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 60:20:20', 'armGroupLabels': ['Carbohydrate challenge breakfast']}, {'name': 'Carbohydrate challenge breakfast+spices', 'type': 'OTHER', 'description': 'In this intervention, subjects are asked to consume 200 ml spices drinks (non-energy flavored water + spices extract). Following 10 min. beverage consumption, subjects will be given standardized high carbohydrate breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 60:20:20', 'armGroupLabels': ['Carbohydrate challenge breakfast+spices']}]}, 'contactsLocationsModule': {'locations': [{'zip': '223 81', 'city': 'Lund', 'state': 'Skåne County', 'country': 'Sweden', 'facility': 'Food for Health Laboratory - Lund University', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Yoghatama Cindya Zanzer, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Lund University'}, {'name': 'Elin Östman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Food for Health Science Centre, Lund University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. PhD.', 'investigatorFullName': 'Elin Östman', 'investigatorAffiliation': 'Lund University'}}}}