HealthyNCT02193438
Physiologic Effect of Spices Ingestion
A study testing Spices intake in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
Human studies have shown that capsaicin, a compound extracted from chilly peppers, can stimulate certain physiologic functions (for example, energy expenditure, thermogenesis, lipid oxidation, heart rate, etc.). Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Spices intake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2011to Aug 2012
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- BMI: 19-25 kg/m2, ≥ 60 kg body weight
- Moderate spicy food eaters
- Having signed the informed consent.
Who cannot join
- Any gastrointestinal disorder
- Subject sensitive or not used to eat spicy food
- Smokers
- Subject with beard or mustache
- Abnormal thyroid function
- Intake of medication that could affect body weight and/or energy expenditure
Show all 14Show fewer
- Weight loss > 5% in the last 3 months
- Under antibiotics or regular treatments (medical or nutritional program) affecting body weight, appetite, energy expenditure, lipid-lowering, hypertension or inflammation or glucose control for the last 3 months or taking hormone replacement therapy
- History of allergy
- Physical activity level > 300 min of moderate or intense exercise per week
- Have a alcohol consumption higher than than 1 drink/day
- Consumption of illicit drugs
- Subject who cannot be expected to comply with the study procedures, including consuming the test products
- Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
Trial locations and contacts
1 site in 1 country.
About this study
Human studies have shown that capsaicin, a compound extracted from chilly peppers, can stimulate certain physiologic functions (for example, energy expenditure, thermogenesis, lipid oxidation, heart rate, etc.).
The purpose of this study is to measure the impact of ingesting various spicy molecules on a set of physiologic parameters compared to a placebo. The molecules were selected for their different sensory properties.
The results of this study will allow us to implement an effective method for measuring the impact of ingesting spices on certain body functions (for example, metabolism and autonomic nervous system activity). This study will also allow us to identify the beneficial properties of eating certain spices.
Read the detailed description
Primary objective and outcome:
The main objective of this study is to establish a methodology to evaluate the acute impact of spice ingestion on metabolism and autonomic nervous system activity.
Primary outcomes:
Impact of the spice on autonomic nervous system activity: Power spectra analysis on heart rate variability (HRV) changes during the 90 post ingestive minutes (measured by ECG).
Impact of the spice on metabolism: Energy expenditure changes during the 90 post ingestive minutes (measured by indirect calorimetry).
As secondary outcomes blood pressure changes and facial temperature changes on specific area (nose, cheeks and forehead) will be evaluated. Substrate oxidation (carbohydrates and fat utilization) and the respiratory quotient (RQ) will be calculated using indirect calorimetry data for energy expenditure measure.
- Conditions
- Healthy
- Being tested
- Spices intake, Placebo
- Keywords
- Heart rate variability, Resting energy expenditure, Facial thermography, Blood pressure, Spices ingestion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spices intakeOther
Also called 3 different spices
Each subject had to ingest a single dose of each of the spices and placebo. Recording of outcomes was realized throughout the 90 minutes following ingestion.
PlaceboOther
Also called Tomato juice
Tomato juice intake
| Study group | Role | What they receive |
|---|---|---|
| Spice 1 | Active comparator | Red chili pepper extract Receives: Other: Placebo |
| Spice 2 | Active comparator | Cinnamon extract Receives: Other: Placebo |
| Spice 3 | Active comparator | Refreshing agent Receives: Other: Placebo |
| Placebo | Placebo comparator | Tomato juice Receives: Other: Spices intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting energy expenditure
Calculation of the resting energy expenditure from continuous measurement of oxygen consumption and carbon dioxid production (indirect calorimetry).
Measured: change from baseline to 90 minutes following product intake
Heart rate variability
Power spectral analysis of heart rate variability from continuous measurement of very low, low and high frequency range electrocardiographic signals.
Measured: Change from baseline to 90 minutes following product intake
Secondary outcomes (3)
Substrat oxidation
Carbohydrate oxidation, lipid oxidation, and respiratory quotient from continuous measurements by indirect calorimetryof oxygen consumption and carbon dioxide production.
Measured: Change from baseline to 90 minutes following product intake
Blood pressure
Standard blood pressure monitoring using an arm cuff
Measured: every 15 minutes over 90 minutes of recording following product intake
Facial skin temperature modification
Measurement of the skin temperature of the face using an infrared camera (FLIR A325)
Measured: Change from baseline to 90 minutes following product intakeover 90 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startMay 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stéphanie Michlig Gonzalez, PhD, Study director, Société des Produits Nestlé (SPN)Maurice Beaumont, MD, PhD, Principal investigator, Société des Produits Nestlé (SPN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193438
- Sponsor's protocol ID
- 10.24.MET
- Status last verified
- Jul 2014
- First submitted
- 16 Jul 2014
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Tomsen N, Alvarez-Berdugo D, Rofes L, Ortega O, Arreola V, Nascimento W, Martin A, Cabib C, Bolivar-Prados M, Mundet L, Legrand C, Clave P, Michlig S. A randomized clinical trial on the acute therapeutic effect of TRPA1 and TRPM8 agonists in patients with oropharyngeal dysphagia. Neurogastroenterol Motil. 2020 Jun;32(6):e13821. doi: 10.1111/nmo.13821. Epub 2020 Feb 16.
PubMed 32064725Michlig S, Merlini JM, Beaumont M, Ledda M, Tavenard A, Mukherjee R, Camacho S, le Coutre J. Effects of TRP channel agonist ingestion on metabolism and autonomic nervous system in a randomized clinical trial of healthy subjects. Sci Rep. 2016 Feb 17;6:20795. doi: 10.1038/srep20795.
PubMed 26883089
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Effect of Spices Ingestion
- ClinicalTrials.gov ID
- NCT02193438
- Acronym / sponsor ID
- 10.24.MET
- Conditions
- Healthy
- Keywords
- Heart rate variability, Resting energy expenditure, Facial thermography, Blood pressure, Spices ingestion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Jul 2014 (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.
Human studies have shown that capsaicin, a compound extracted from chilly peppers, can stimulate certain physiologic functions (for example, energy expenditure, thermogenesis, lipid oxidation, heart rate, etc.).
The purpose of this study is to measure the impact of ingesting various spicy molecules on a set of physiologic parameters compared to a placebo. The molecules were selected for their different sensory properties.
The results of this study will allow us to implement an effective method for measuring the impact of ingesting spices on certain body functions (for example, metabolism and autonomic nervous system activity). This study will also allow us to identify the beneficial properties of eating certain spices.
Detailed description
Primary objective and outcome:
The main objective of this study is to establish a methodology to evaluate the acute impact of spice ingestion on metabolism and autonomic nervous system activity.
Primary outcomes:
Impact of the spice on autonomic nervous system activity: Power spectra analysis on heart rate variability (HRV) changes during the 90 post ingestive minutes (measured by ECG).
Impact of the spice on metabolism: Energy expenditure changes during the 90 post ingestive minutes (measured by indirect calorimetry).
As secondary outcomes blood pressure changes and facial temperature changes on specific area (nose, cheeks and forehead) will be evaluated. Substrate oxidation (carbohydrates and fat utilization) and the respiratory quotient (RQ) will be calculated using indirect calorimetry data for energy expenditure measure.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Spice 1 | Active comparator | Other: PlaceboRed chili pepper extract |
| Spice 2 | Active comparator | Other: PlaceboCinnamon extract |
| Spice 3 | Active comparator | Other: PlaceboRefreshing agent |
| Placebo | Placebo comparator | Other: Spices intakeTomato juice |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- BMI: 19-25 kg/m2, ≥ 60 kg body weight
- Moderate spicy food eaters
- Having signed the informed consent.
Key exclusion criteria (14 listed)
- Any gastrointestinal disorder
- Subject sensitive or not used to eat spicy food
- Smokers
- Subject with beard or mustache
- Abnormal thyroid function
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 |
|---|---|---|
| Spices intakeAlso: 3 different spicesEach subject had to ingest a single dose of each of the spices and placebo. Recording of outcomes was realized throughout the 90 minutes following ingestion. | Other | Placebo |
| PlaceboAlso: Tomato juiceTomato juice intake | Other | Spice 1, Spice 2, Spice 3 |
Primary outcome
Resting energy expenditure
Time frame: change from baseline to 90 minutes following product intake
Calculation of the resting energy expenditure from continuous measurement of oxygen consumption and carbon dioxid production (indirect calorimetry).
Heart rate variability
Time frame: Change from baseline to 90 minutes following product intake
Power spectral analysis of heart rate variability from continuous measurement of very low, low and high frequency range electrocardiographic signals.
3 secondary outcomes
Substrat oxidation
Time frame: Change from baseline to 90 minutes following product intake
Blood pressure
Time frame: every 15 minutes over 90 minutes of recording following product intake
Facial skin temperature modification
Time frame: Change from baseline to 90 minutes following product intakeover 90 min
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 17 Jul 2014.
- Derived from this study: PubMed 32064725Tomsen N, Alvarez-Berdugo D, Rofes L, Ortega O, Arreola V, Nascimento W, Martin A, Cabib C, Bolivar-Prados M, Mundet L, Legrand C, Clave P, Michlig S. A randomized clinical trial on the acute therapeutic effect of TRPA1 and TRPM8 agonists in patients with oropharyngeal dysphagia. Neurogastroenterol Motil. 2020 Jun;32(6):e13821. doi: 10.1111/nmo.13821. Epub 2020 Feb 16.
- Derived from this study: PubMed 26883089Michlig S, Merlini JM, Beaumont M, Ledda M, Tavenard A, Mukherjee R, Camacho S, le Coutre J. Effects of TRP channel agonist ingestion on metabolism and autonomic nervous system in a randomized clinical trial of healthy subjects. Sci Rep. 2016 Feb 17;6:20795. doi: 10.1038/srep20795.
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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.
Stéphanie Michlig Gonzalez, PhD study director
Société des Produits Nestlé (SPN)
Maurice Beaumont, MD, PhD principal investigator
Société des Produits Nestlé (SPN)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spices intake in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 4 inclusion and 14 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 17 Jul 2014. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Resting energy expenditure (time frame: change from baseline to 90 minutes following product intake). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02193438, which also lists 2 linked publications.
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 17 Jul 2014.