Physiologic Effect of Spices Ingestion

NCT02193438 | Completed

• 1 other identifier: 10.24.MET
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Heart rate variability; Resting energy expenditure; Facial thermography; Blood pressure; Spices ingestion

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Substrat oxidation

  Change from baseline to 90 minutes following product intake

• Blood pressure

  every 15 minutes over 90 minutes of recording following product intake

• Facial skin temperature modification

  Change from baseline to 90 minutes following product intakeover 90 min

Study Arms (4)

Spice 1

ACTIVE COMPARATOR

Red chili pepper extract

Other: Placebo

Spice 2

ACTIVE COMPARATOR

Cinnamon extract

Other: Placebo

Spice 3

ACTIVE COMPARATOR

Refreshing agent

Other: Placebo

Placebo

PLACEBO COMPARATOR

Tomato juice

Other: Spices intake

Interventions

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.

Also known as: 3 different spices

Placebo

Placebo OTHER

Tomato juice intake

Also known as: Tomato juice

Spice 1; Spice 2; Spice 3

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• BMI: 19-25 kg/m2, ≥ 60 kg body weight
• Moderate spicy food eaters
• Having signed the informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

NESTEC / Metabolic Unit

Lausanne, 1026, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 32064725 DERIVED

• 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.

  PMID: 26883089 DERIVED

Study Officials

• Stéphanie Michlig Gonzalez, PhD

  Société des Produits Nestlé (SPN)

  STUDY DIRECTOR

• Maurice Beaumont, MD, PhD

  Société des Produits Nestlé (SPN)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 17, 2014
• Study Start: May 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 17, 2014

Record last verified: 2014-07

Locations

CH (1)