Physiologic Effect of Spices Ingestion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physiologic Effect of Spices Ingestion

Conditions
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Healthy

Intervention / Treatment
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* Other: Spices intake
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy BMI: 19-25 kg/m2, ≥ 60 kg body weight Moderate spicy food eaters Having signed the informed consent. Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spice 1<br>Red chili pepper extract | Other: Placebo<br>* Tomato juice intake<br>* Other names: Tomato juice;|
| Active Comparator: Spice 2<br>Cinnamon extract | Other: Placebo<br>* Tomato juice intake<br>* Other names: Tomato juice;|
| Active Comparator: Spice 3<br>Refreshing agent | Other: Placebo<br>* Tomato juice intake<br>* Other names: Tomato juice;|
| Placebo Comparator: Placebo<br>Tomato juice | Other: Spices intake<br>* 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.<br>* Other names: 3 different spices;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting energy expenditure | Calculation of the resting energy expenditure from continuous measurement of oxygen consumption and carbon dioxid production (indirect calorimetry). | 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. | Change from baseline to 90 minutes following product intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substrat oxidation | Carbohydrate oxidation, lipid oxidation, and respiratory quotient from continuous measurements by indirect calorimetryof oxygen consumption and carbon dioxide production. | Change from baseline to 90 minutes following product intake | 
| Blood pressure | Standard blood pressure monitoring using an arm cuff | 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) | Change from baseline to 90 minutes following product intakeover 90 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart rate variability, Resting energy expenditure, Facial thermography, Blood pressure, Spices ingestion