Mastication and Energy Expenditure in Normal Weight and Obese People

NCT04050930 | Unknown

• 2 other identifiers: PHRC IR 2010 BOIRIE2018-A00724-51
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nutrition; Mastication

Keywords

mastication; postprandial thermogenesis; autonomic nervous system; cephalic phase reflex; food texture

Outcome Measures

Primary Outcomes (4)

• Measure of energy expenditure by Indirect calorimetry

  effect of mastication without swallowing on energy expenditure (kcal/24h) in normal weight and obese people. This will be measured by indirect calorimetry (Under Canopy of the system Fitmate)

  1 hour 30 minutes

• Measure of cardiac activity

  effect of mastication without swallowing on cardiac activity (R-R interval) in normal weight and obese people measured by electrocardiogram

  1 hour 30 minutes

• Measure of masticatory muscle activity

  effect of mastication without swallowing on masticatory muscle activity (microvolt.s in normal weight and obese people measured by electromyography

  1 hour 30 minutes

• Estimate of the hormonal response

  effect of mastication without swallowing on hormonal response in normal weight and obese people. This will be estimate by their concentration and their kinetic of appearance in the blood compartment, and by comparisons of concentration values with basal level, also expressed in "area under the curve" values.

  1 hour 30 minutes

Secondary Outcomes (8)

• effect of sensory information from oral cavity on energy expenditure by Indirect calorimetry

  1 hour 30 minutes

• effect of sensory information from oral cavity on cardiac activity

  1 hour 30 minutes

• effect of sensory information from oral cavity on hormonal response

  1 hour 30 minutes

• effect of sensory information from oral cavity on masticatory muscle activity

  1 hour 30 minutes

• cardiac activity while sleeping measured by electrocardiogram

  8-10 hours (night)

Study Arms (2)

Normal weight, normo-dented

EXPERIMENTAL

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

Other: Mastication

Obese, normo-dented

EXPERIMENTAL

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

Other: Mastication

Interventions

Mastication 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

Normal weight, normo-dented; Obese, normo-dented

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \< 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator
• University Hospital, Clermont-Ferrand: lead
• Centre de Recherche en Odontologie Clinique (CROC), Faculté Dentaire: collaborator
• CHU Saint Etienne Nord, Service de Physiologie Clinique et Exercice: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

RECRUITING

MeSH Terms

Interventions

Mastication

Intervention Hierarchy (Ancestors)

Eating; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Yves BOIRIE, Professor

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 9, 2019
• Study Start: December 5, 2018
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 9, 2019

Record last verified: 2019-06

Locations

FR (1)