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Completed

NCT Number: NCT02193438

Physiologic Effect of Spices Ingestion

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.

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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

NESTEC / Metabolic Unit

Lausanne, 1026, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spices intake

Other

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

Placebo

Other

Tomato juice intake

Other names: Tomato juice

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

  2. Blood pressure

    Time frame: every 15 minutes over 90 minutes of recording following product intake

    Standard blood pressure monitoring using an arm cuff

  3. 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)

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 17, 2014
Registry last updated
Jul 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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