Clinical trial NCT02193438: Physiologic Effect of Spices Ingestion
Official title: Physiologic Effect of Spices Ingestion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Heart rate variability
Resting energy expenditure
Facial thermography
Blood pressure
Spices ingestion
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-07-17
Enrollment: 19
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Resting energy expenditure
timeFrame: change from baseline to 90 minutes following product intake
measure: Heart rate variability
timeFrame: Change from baseline to 90 minutes following product intake
Secondary outcomes:
measure: Substrat oxidation
timeFrame: Change from baseline to 90 minutes following product intake
measure: Blood pressure
timeFrame: every 15 minutes over 90 minutes of recording following product intake
measure: Facial skin temperature modification
timeFrame: Change from baseline to 90 minutes following product intakeover 90 min
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: NESTEC / Metabolic Unit
Study officials:
affiliation: Société des Produits Nestlé (SPN)
name: Stéphanie Michlig Gonzalez, PhD
role: STUDY_DIRECTOR
affiliation: Société des Produits Nestlé (SPN)
name: Maurice Beaumont, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tomsen N, Alvarez-Berdugo D, Rofes L, Ortega O, Arreola V, Nascimento W, Martin A, Cabib C, Bolivar-Prados M, Mundet L, Legrand C, Clave P, Michlig S. A randomized clinical trial on the acute therapeutic effect of TRPA1 and TRPM8 agonists in patients with oropharyngeal dysphagia. Neurogastroenterol Motil. 2020 Jun;32(6):e13821. doi: 10.1111/nmo.13821. Epub 2020 Feb 16.
citation: Michlig S, Merlini JM, Beaumont M, Ledda M, Tavenard A, Mukherjee R, Camacho S, le Coutre J. Effects of TRP channel agonist ingestion on metabolism and autonomic nervous system in a randomized clinical trial of healthy subjects. Sci Rep. 2016 Feb 17;6:20795. doi: 10.1038/srep20795.