Physiologic Effect of Spices Ingestion

Healthy Clinical Trial

Official title:

Physiologic Effect of Spices Ingestion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193438
• Other study ID #: 10.24.MET
• Status: Completed
• Phase: N/A
• First received: July 16, 2014
• Last updated: July 16, 2014
• Start date: May 2011
• Est. completion date: August 2012

Study information

• Verified date: July 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical 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.).

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• 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

Locations

Country	Name	City	State
Switzerland	NESTEC / Metabolic Unit	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Blood pressure	Standard blood pressure monitoring using an arm cuff	every 15 minutes over 90 minutes of recording following product intake	No
Secondary	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	No