Physiologic Effect of Spices Ingestion

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Placebo; Other: Spices intake

• Registration Number: NCT02193438
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief 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.).

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 Timeline

• Study Start: 2011-05
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-07
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-16
• Last Update Submitted: 2014-07-16
• Study First Posted: 2014-07-17
• Last Update Posted: 2014-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Spice 2	Placebo	Cinnamon extract
Placebo	Spices intake	Tomato juice
Spice 1	Placebo	Red chili pepper extract
Spice 3	Placebo	Refreshing agent

Primary Outcome Measures

Name	Time	Method
Resting energy expenditure	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	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.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	every 15 minutes over 90 minutes of recording following product intake	Standard blood pressure monitoring using an arm cuff
Substrat oxidation	Change from baseline to 90 minutes following product intake	Carbohydrate oxidation, lipid oxidation, and respiratory quotient from continuous measurements by indirect calorimetryof oxygen consumption and carbon dioxide production.
Facial skin temperature modification	Change from baseline to 90 minutes following product intakeover 90 min	Measurement of the skin temperature of the face using an infrared camera (FLIR A325)

Trial Locations

Locations (1)

NESTEC / Metabolic Unit; 🇨🇭 Lausanne, Switzerland