NCT00841893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Aug 2008

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
Last Updated

February 11, 2009

Status Verified

February 1, 2009

Enrollment Period

4 months

First QC Date

February 10, 2009

Last Update Submit

February 10, 2009

Conditions

Healthy

Keywords

ThermogenesisMeal-induced thermogenesisEnergy expenditureFat oxidationCarbohydrate oxidationBioactive ingredientSpice

Outcome Measures

Primary Outcomes (1)

  • Energy expenditure (resting)/Meal-induced thermogenesis

    November 2008

Secondary Outcomes (4)

  • VAS-scores for different appetite parameters (incl. satiety, hunger, fullness, prospective food intake, well-being, thirst etc.)

    November 2008

  • Blood pressure

    November 2008

  • Heart rate

    November 2008

  • Substrate oxidation (fat and carbohydrate)

    November 2008

Study Arms (2)

1

EXPERIMENTAL

Mustard

Dietary Supplement: Mustard (dijon)

2

EXPERIMENTAL

Placebo

Dietary Supplement: Placebo

Interventions

Mustard (dijon)DIETARY_SUPPLEMENT

The specific spice added to a brunch meal

1
PlaceboDIETARY_SUPPLEMENT

Placebo added to a brunch meal

2

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • healthy and not using medication (regularly)
  • normal weight
  • non-smoker
  • tolerate and like spicy food
  • stable body weight last two months

You may not qualify if:

  • increased blood pressure
  • mental, metabolic and chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition, Faculty of Life Sciences, university of Copenhagen

Frederiksberg C, Copenhagen, DK-1958, Denmark

Location

MeSH Terms

Interventions

Amines

Intervention Hierarchy (Ancestors)

Organic Chemicals

Study Officials

  • Arne Astrup, Professor MD

    Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 11, 2009

Record last verified: 2009-02

Locations

DK(1)