Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-03-16 @ 8:03 PM
Study NCT ID:
NCT00611156
Status:
COMPLETED
Last Update Posted:
2008-02-08
First Post:
2008-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examination of the Effects of Four Different Spices on Energy Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713927', 'term': 'ginger extract'}, {'id': 'C000723805', 'term': 'black pepper oil'}, {'id': 'D000588', 'term': 'Amines'}], 'ancestors': [{'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-07', 'studyFirstSubmitDate': '2008-01-28', 'studyFirstSubmitQcDate': '2008-02-07', 'lastUpdatePostDateStruct': {'date': '2008-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'energy expenditure', 'timeFrame': 'November 2007'}], 'secondaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': 'December 2007'}, {'measure': 'heart rate', 'timeFrame': 'December 2007'}, {'measure': 'VAS-scores for appetite, hunger, fullness, etc. - and palatability', 'timeFrame': 'November 2007'}, {'measure': 'tolerance', 'timeFrame': 'November 2007'}, {'measure': 'Fat and carbohydrate oxidation', 'timeFrame': 'November 2007'}, {'measure': 'Meal-induced thermogenesis', 'timeFrame': 'November 2007'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thermogenesis', 'Meal-induced thermogenesis', 'energy expenditure', 'fat oxidation', 'bioactive ingredients', 'spices', 'ginger', 'horseradish', 'black pepper', 'mustard'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '23021155', 'type': 'DERIVED', 'citation': 'Gregersen NT, Belza A, Jensen MG, Ritz C, Bitz C, Hels O, Frandsen E, Mela DJ, Astrup A. Acute effects of mustard, horseradish, black pepper and ginger on energy expenditure, appetite, ad libitum energy intake and energy balance in human subjects. Br J Nutr. 2013 Feb 14;109(3):556-63. doi: 10.1017/S0007114512001201. Epub 2012 Jul 5.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to examine whether four different spices (ginger, black pepper, horseradish and mustard) are able to increase energy metabolism.\n\nSince chili and other spices have been shown to increase energy expenditure compared to placebo, we expect that some or all of the four spices may actually increase energy expenditure - 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. 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 use 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* abnormal EKG\n* mental, metabolic and chronic diseases'}, 'identificationModule': {'nctId': 'NCT00611156', 'briefTitle': 'Examination of the Effects of Four Different Spices on Energy Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Bioactive Food Ingredients and Energy Metabolism: The Effects of Ginger, Black Pepper, Horseradish and Mustard on Meal-Induced Thermogenesis and Fat Oxidation', 'orgStudyIdInfo': {'id': 'B228-IHE-2006-NTG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Spice', 'interventionNames': ['Dietary Supplement: ginger']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Spice', 'interventionNames': ['Dietary Supplement: black pepper']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'Spice', 'interventionNames': ['Dietary Supplement: horseradish']}, {'type': 'EXPERIMENTAL', 'label': 'D', 'description': 'Spice', 'interventionNames': ['Dietary Supplement: mustard']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'E', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'ginger', 'type': 'DIETARY_SUPPLEMENT', 'description': 'added to a brunch meal', 'armGroupLabels': ['A']}, {'name': 'black pepper', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Added to a brunch meal', 'armGroupLabels': ['B']}, {'name': 'horseradish', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Added to a brunch meal', 'armGroupLabels': ['C']}, {'name': 'mustard', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Added to a brunch meal', 'armGroupLabels': ['D']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Added to a bruch meal', 'armGroupLabels': ['E']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-1958', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Department of Human Nutrition, The Royal Veterinary and Agricultural University', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'overallOfficials': [{'name': 'Arne Astrup, Professor MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Human Nutrition, RVAU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Aarhus', 'class': 'OTHER'}]}}}