Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT00841893
Status:
COMPLETED
Last Update Posted:
2009-02-11
First Post:
2009-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Specific Spice on Energy Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000588', 'term': 'Amines'}], 'ancestors': [{'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-10', 'studyFirstSubmitDate': '2009-02-10', 'studyFirstSubmitQcDate': '2009-02-10', 'lastUpdatePostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy expenditure (resting)/Meal-induced thermogenesis', 'timeFrame': 'November 2008'}], 'secondaryOutcomes': [{'measure': 'VAS-scores for different appetite parameters (incl. satiety, hunger, fullness, prospective food intake, well-being, thirst etc.)', 'timeFrame': 'November 2008'}, {'measure': 'Blood pressure', 'timeFrame': 'November 2008'}, {'measure': 'Heart rate', 'timeFrame': 'November 2008'}, {'measure': 'Substrate oxidation (fat and carbohydrate)', 'timeFrame': 'November 2008'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thermogenesis', 'Meal-induced thermogenesis', 'Energy expenditure', 'Fat oxidation', 'Carbohydrate oxidation', 'Bioactive ingredient', 'Spice'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to examine whether a specific spice is capable of affecting energy metabolism.\n\nSince chili and other spices have been shown to increase energy expenditure and in some cases also affect energy intake/appetite compared to placebo, the investigators expect that the specific spice may actually increase energy expenditure and potentially also decrease appetite - although not to a large degree.', 'detailedDescription': 'Several pungent food ingredients, such as chili, and also other bioactive food ingredients, e.g. green tea, have been shown to be able to increase energy expenditure and fat oxidation during the hours following a meal containing the bioactive ingredient. Furthermore, we will also look at the subjects own feelings of appetite and thereby examine whether the appetite is affected by the spicy food, since a few studies have suggested an effect of bioactive ingredients on appetite/energy intake. We expect to see some small effects on these parameters.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male\n* healthy and not using medication (regularly)\n* normal weight\n* non-smoker\n* tolerate and like spicy food\n* stable body weight last two months\n\nExclusion Criteria:\n\n* increased blood pressure\n* mental, metabolic and chronic diseases'}, 'identificationModule': {'nctId': 'NCT00841893', 'briefTitle': 'Effects of a Specific Spice on Energy Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Effects of a Specific Spice on Energy Expenditure, Substrate Oxidation, Appetite and Energy Intake', 'orgStudyIdInfo': {'id': 'B253-IHE-spice2-NTG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Mustard', 'interventionNames': ['Dietary Supplement: Mustard (dijon)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Mustard (dijon)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The specific spice added to a brunch meal', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo added to a brunch meal', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-1958', 'city': 'Frederiksberg C', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Human Nutrition, Faculty of Life Sciences, university of Copenhagen'}], 'overallOfficials': [{'name': 'Arne Astrup, Professor MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Nikolaj Ture Gregersen/Ph.D.student', 'oldOrganization': 'Department of Human Nutrition, University of Copenhagen'}}}}