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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00841893
Other study ID # B253-IHE-spice2-NTG
Secondary ID
Status Completed
Phase N/A
First received February 10, 2009
Last updated February 10, 2009
Start date August 2008
Est. completion date December 2008

Study information

Verified date February 2009
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- male

- healthy and not using medication (regularly)

- normal weight

- non-smoker

- tolerate and like spicy food

- stable body weight last two months

Exclusion Criteria:

- increased blood pressure

- mental, metabolic and chronic diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Mustard (dijon)
The specific spice added to a brunch meal
Placebo
Placebo added to a brunch meal

Locations

Country Name City State
Denmark Department of Human Nutrition, Faculty of Life Sciences, university of Copenhagen Frederiksberg C Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Energy expenditure (resting)/Meal-induced thermogenesis November 2008 No
Secondary VAS-scores for different appetite parameters (incl. satiety, hunger, fullness, prospective food intake, well-being, thirst etc.) November 2008 Yes
Secondary Blood pressure November 2008 Yes
Secondary Heart rate November 2008 Yes
Secondary Substrate oxidation (fat and carbohydrate) November 2008 No
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