HealthyNCT00841893
Effects of a Specific Spice on Energy Metabolism
A study testing Mustard (dijon) in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mustard (dijon)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- healthy and not using medication (regularly)
- normal weight
- non-smoker
- tolerate and like spicy food
- stable body weight last two months
Who cannot join
- increased blood pressure
- mental, metabolic and chronic diseases
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, Faculty of Life Sciences, university of Copenhagen
Frederiksberg C, Copenhagen, DK-1958
About this study
Official title: Effects of a Specific Spice on Energy Expenditure, Substrate Oxidation, Appetite and Energy Intake
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Mustard (dijon), Placebo
- Keywords
- Thermogenesis, Meal-induced thermogenesis, Energy expenditure, Fat oxidation, Carbohydrate oxidation, Bioactive ingredient, Spice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mustard (dijon)Dietary supplement
The specific spice added to a brunch meal
PlaceboDietary supplement
Placebo added to a brunch meal
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Mustard Receives: Dietary Supplement: Mustard (dijon) |
| 2 | Experimental | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure (resting)/Meal-induced thermogenesis
Measured: November 2008
Secondary outcomes (4)
VAS-scores for different appetite parameters (incl. satiety, hunger, fullness, prospective food intake, well-being, thirst etc.)
Measured: November 2008
Blood pressure
Measured: November 2008
Heart rate
Measured: November 2008
Substrate oxidation (fat and carbohydrate)
Measured: November 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Arne Astrup, Professor MD, Study chair, Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841893
- Sponsor's protocol ID
- B253-IHE-spice2-NTG
- Status last verified
- Feb 2009
- First submitted
- 10 Feb 2009
- Last updated
- 11 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Specific Spice on Energy Expenditure, Substrate Oxidation, Appetite and Energy Intake
- ClinicalTrials.gov ID
- NCT00841893
- Acronym / sponsor ID
- B253-IHE-spice2-NTG
- Conditions
- Healthy
- Keywords
- Thermogenesis, Meal-induced thermogenesis, Energy expenditure, Fat oxidation, Carbohydrate oxidation, Bioactive ingredient, Spice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Mustard (dijon)Mustard |
| 2 | Experimental | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- male
- healthy and not using medication (regularly)
- normal weight
- non-smoker
- tolerate and like spicy food
Key exclusion criteria (2 listed)
- increased blood pressure
- mental, metabolic and chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mustard (dijon)The specific spice added to a brunch meal | Dietary supplement | 1 |
| PlaceboPlacebo added to a brunch meal | Dietary supplement | 2 |
Primary outcome
Energy expenditure (resting)/Meal-induced thermogenesis
Time frame: November 2008
4 secondary outcomes
VAS-scores for different appetite parameters (incl. satiety, hunger, fullness, prospective food intake, well-being, thirst etc.)
Time frame: November 2008
Blood pressure
Time frame: November 2008
Heart rate
Time frame: November 2008
Substrate oxidation (fat and carbohydrate)
Time frame: November 2008
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Astrup, Professor MD study chair
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mustard (dijon) in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure (resting)/Meal-induced thermogenesis (time frame: November 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2009.