Mastication and Energy Expenditure in Normal Weight and Obese People

NCT ID: NCT04050930

Last Updated: 2019-08-09

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2020-12-31

Brief Summary

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The objective of the study is to analyze the specific role of physical properties of food and mastication in the cephalic phase reflex of thermogenesis, and the involvement of the autonomic nervous system in the implementation of this reflex.

The hypothesis of the study is that oral stimulation elicited by food properties during mastication can generate changes in the amplitude of variation of thermogenesis, and that these changes are distinct from those attributable to the thermal effect of food during digestion.

Detailed Description

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A group of 12 subjects presenting a normal weight and a group of 12 obese subjects, with a good general health and a good dental state will be constituted. They will participate to 5 different recording sessions during which they will be invited to chew and spit out foods and chewing gums of different hardness. During recording sessions with mastication and no-mastication periods, gas exchange (O2 concentration), cardiac activity (electrocardiography) and muscular activity of masticatory muscles (electromyography) will be recorded. Blood samples will be collected during one of the sessions to analyse the kinetic of appearance of some hormones in the blood compartment during or just after mastication. The selected hormones are involved in the eating behaviour and its regulation (ghrelin, peptide C, peptide YY and glucose-like peptide 1). From these recordings, energy expenditure, heart rate variability, intensity of masticatory muscle contraction, and hormone blood appearance will be analysed in link with the nature and hardness of the food chewed. Since the food bolus is spit out after mastication (without any swallowing = sham-feeding), the changes observed in theses variables will be directly attributed to sensory information coming from oral cavity during mastication. Food choice and sport activity of each volunteer will be taken into account to compare the results obtained for the two groups (normal weight and obese).

The work will produce more data and evidence on the contribution of oral signals attributable to the food in the regulation of the energy balance. The results will also bring more knowledge on the involvement of the autonomic nervous system. Comparison of the results obtained for the two groups (normal weight and obese people), will bring some positive outcomes which could be useful in the fight against obesity.

Conditions

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Nutrition Mastication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

each volunteer will participate to the whole protocol, that is 5 recording sessions, which, except the first session, will be organized in a random order for each volunteer
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Normal weight, normo-dented

healthy young male presenting a good oral health ad a normal weight

Group Type EXPERIMENTAL

Mastication

Intervention Type OTHER

Simultaneous recordings of postprandial thermogenesis (gas exchange), cardiac activity (ECG), masticatory muscle contraction (EMG), and blood collection, during alternating periods of no-mastication or mastication of natural foods or chewing gums of different hardness

Obese, normo-dented

healthy young male presenting a first level of obesity, and a good oral health

Group Type EXPERIMENTAL

Mastication

Intervention Type OTHER

Simultaneous recordings of postprandial thermogenesis (gas exchange), cardiac activity (ECG), masticatory muscle contraction (EMG), and blood collection, during alternating periods of no-mastication or mastication of natural foods or chewing gums of different hardness

Interventions

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Mastication

Simultaneous recordings of postprandial thermogenesis (gas exchange), cardiac activity (ECG), masticatory muscle contraction (EMG), and blood collection, during alternating periods of no-mastication or mastication of natural foods or chewing gums of different hardness

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

19 \< body mass index \< 25 kg/m2 for the normal weight group 30 \< body mass index \< 35 kg/m2 for the obese group Good general health

Exclusion Criteria

* sport activity
* Smoking in the 6 months before the beginning of the study
* Regular alcohol consumption (more than 4 unit/day)
* Medication that may interfere with the results of the study (beta-blockers, corticoids, anti-inflammatories, thyroid hormone, insulin, antiarrhythmics) or that may have an effect on salivation or muscular activity
* Oral or dental pathology (including pain), current oral care
* Orthodontic treatment in the 3 years before the study
* Weigh gain or weight loss of more than 10% in the 3 last months
* Thyroid disturbance
* High blood pressure
* Cardiac activity anomaly
* Anomaly for one of the biological elements : complete blood count, fasting blood glucose, glycated haemoglobin, thyroid hormone (TSH), sedimentation rate \> 8mm, CRP rate \> 10ml/L
* Allergies, intolerance or disgust for one of the food tested
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role collaborator

Centre de Recherche en Odontologie Clinique (CROC), Faculté Dentaire

UNKNOWN

Sponsor Role collaborator

CHU Saint Etienne Nord, Service de Physiologie Clinique et Exercice

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yves BOIRIE, Professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Facility Contacts

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Lise Laclautre

Role: primary

Other Identifiers

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2018-A00724-51

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC IR 2010 BOIRIE

Identifier Type: -

Identifier Source: org_study_id

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