Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2011-05-31
2012-08-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TRIPLE
Study Groups
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Spice 1
Red chili pepper extract
Placebo
Tomato juice intake
Spice 2
Cinnamon extract
Placebo
Tomato juice intake
Spice 3
Refreshing agent
Placebo
Tomato juice intake
Placebo
Tomato juice
Spices intake
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.
Interventions
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Spices intake
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.
Placebo
Tomato juice intake
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI: 19-25 kg/m2, ≥ 60 kg body weight
* Moderate spicy food eaters
* Having signed the informed consent.
Exclusion Criteria
* 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
* 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
20 Years
50 Years
MALE
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Stéphanie Michlig Gonzalez, PhD
Role: STUDY_DIRECTOR
Société des Produits Nestlé (SPN)
Maurice Beaumont, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Société des Produits Nestlé (SPN)
Locations
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NESTEC / Metabolic Unit
Lausanne, , Switzerland
Countries
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References
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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.
Michlig 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.
Other Identifiers
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10.24.MET
Identifier Type: -
Identifier Source: org_study_id
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