Physiologic Effect of Spices Ingestion

July 16, 2014 updated by: Nestlé

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1026
        • NESTEC / Metabolic Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Spice 1
Red chili pepper extract
Other: Placebo
Tomato juice intake
Other Names:
  • Tomato juice
Active Comparator: Spice 2
Cinnamon extract
Other: Placebo
Tomato juice intake
Other Names:
  • Tomato juice
Active Comparator: Spice 3
Refreshing agent
Other: Placebo
Tomato juice intake
Other Names:
  • Tomato juice
Placebo Comparator: Placebo
Tomato juice
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.
Other Names:
  • 3 different spices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
change from baseline to 90 minutes following product intake
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.
Change from baseline to 90 minutes following product intake

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Substrat oxidation
Time Frame: 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.
Change from baseline to 90 minutes following product intake
Blood pressure
Time Frame: every 15 minutes over 90 minutes of recording following product intake
Standard blood pressure monitoring using an arm cuff
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Study Director: Stéphanie Michlig Gonzalez, PhD, Nestlé
  • Principal Investigator: Maurice Beaumont, MD, PhD, Nestlé

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

July 16, 2014

First Posted (Estimate)

July 17, 2014

Study Record Updates

Last Update Posted (Estimate)

July 17, 2014

Last Update Submitted That Met QC Criteria

July 16, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10.24.MET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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