Physiologic Effect of Spices Ingestion

NCT ID: NCT02193438

Last Updated: 2014-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Spice 1

Red chili pepper extract

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

Tomato juice intake

Spice 2

Cinnamon extract

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

Tomato juice intake

Spice 3

Refreshing agent

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

Tomato juice intake

Placebo

Tomato juice

Group Type PLACEBO_COMPARATOR

Spices intake

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Placebo

Tomato juice intake

Intervention Type OTHER

Other Intervention Names

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3 different spices Tomato juice

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphanie Michlig Gonzalez, PhD

Role: STUDY_DIRECTOR

Société des Produits Nestlé (SPN)

Maurice Beaumont, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Société des Produits Nestlé (SPN)

Locations

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NESTEC / Metabolic Unit

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 32064725 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26883089 (View on PubMed)

Other Identifiers

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10.24.MET

Identifier Type: -

Identifier Source: org_study_id

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