Effects of a Specific Spice on Energy Metabolism
| Tracking Information | |||||
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| First Received Date ICMJE | February 10, 2009 | ||||
| Last Updated Date | February 10, 2009 | ||||
| Start Date ICMJE | August 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Energy expenditure (resting)/Meal-induced thermogenesis [ Time Frame: November 2008 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of a Specific Spice on Energy Metabolism | ||||
| Official Title ICMJE | Effects of a Specific Spice on Energy Expenditure, Substrate Oxidation, Appetite and Energy Intake | ||||
| Brief Summary | The objective of this study is to examine whether a specific spice is capable of affecting energy metabolism. Since 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 16 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00841893 | ||||
| Other Study ID Numbers ICMJE | B253-IHE-spice2-NTG | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Nikolaj Ture Gregersen/Ph.D.student, Department of Human Nutrition, University of Copenhagen | ||||
| Study Sponsor ICMJE | University of Copenhagen | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Copenhagen | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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