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NutritionMASTICALNCT04050930

Mastication and Energy Expenditure in Normal Weight and Obese People

A study testing Mastication in people with Nutrition and Mastication, run by University Hospital, Clermont-Ferrand at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for
Nutrition, Mastication
What is being tested?
Mastication
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteFrance
Study dates
5 Dec 2018to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 30 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Patrick LACARIN contact

04 73 75 11 95

placarin@chu-clermontferrand.fr

France1 site, 1 recruiting

  • CHU de Clermont-Ferrand

    Clermont-Ferrand, Auvergne, 63003

    Lise Laclautre, promo_interne_drci@chu-clermontferrand.fr

    Yves BOIRIE, Professor

    Recruiting

Other trials in France

About this study

Official title: Mastication Involvement in Postprandial Thermogenesis Via Autonomic Nervous System Activation in Normal Weight and Obese People

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.

Read the detailed description

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.

Being tested
Mastication
Keywords
mastication, postprandial thermogenesis, autonomic nervous system, cephalic phase reflex, food texture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MasticationOther

    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

Study groups in NCT04050930
Study groupRoleWhat they receive
Normal weight, normo-dentedExperimentalhealthy young male presenting a good oral health ad a normal weight
Receives: Other: Mastication
Obese, normo-dentedExperimentalhealthy young male presenting a first level of obesity, and a good oral health
Receives: Other: Mastication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 1 hour 30 minutes

  2. Measure of cardiac activity

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

    Measured: 1 hour 30 minutes

  3. 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

    Measured: 1 hour 30 minutes

  4. 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.

    Measured: 1 hour 30 minutes

Secondary outcomes (8)

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

    effect of various oral information coming from oral cavity during mastication (food hardness, type of food…) on energy expenditure (kcal/24h) in normal weight and obese people. This will be measured by indirect calorimetry (Under Canopy of the system Fitmate)

    Measured: 1 hour 30 minutes

  2. effect of sensory information from oral cavity on cardiac activity

    effect of various oral information coming from oral cavity during mastication (food hardness, type of food…) on cardiac activity (R-R interval) in normal weight and obese people. This will be measured by electrocardiogram.

    Measured: 1 hour 30 minutes

  3. effect of sensory information from oral cavity on hormonal response

    effect of various oral information coming from oral cavity during mastication (food hardness, type of food…) 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.

    Measured: 1 hour 30 minutes

  4. effect of sensory information from oral cavity on masticatory muscle activity

    effect of various oral information coming from oral cavity during mastication (food hardness, type of food…) on masticatory muscle activity (microvolt.s) in normal weight and obese people. This will be measured by electromyography

    Measured: 1 hour 30 minutes

  5. cardiac activity while sleeping measured by electrocardiogram

    evaluation of the general tonus of the autonomic nervous system in normal weight and obese people (R-R interval measured by electrocardiogram)

    Measured: 8-10 hours (night)

  6. cardiac activity (frequency analysis) while sleeping measured by electrocardiogram

    evaluation of the general tonus of the autonomic nervous system in normal weight and obese people

    Measured: 8-10 hours (night)

  7. global characterization of sport activity

    evaluation of the mean energy expenditure in link with physical activity (kcal/time unit) to have a global characterization of the volunteer. This will be done by the app WellBeNet wich contains eMouv for sport activities.

    Measured: 4 consecutive days

  8. global characterization of food choices

    evaluation of the mean energy expenditure in link with food choices and food habits (food portion, score), to have a global characterization of the volunteer. This will be done by the app WellBeNet wich contains NutriQuantic for food choices

    Measured: 4 consecutive days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2019
  2. Study start5 Dec 2018
  3. Primary completionJun 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04050930
Sponsor's protocol ID
PHRC IR 2010 BOIRIE
Other IDs
2018-A00724-51
Acronym
MASTICAL
Status last verified
Jun 2019
First submitted
26 Jul 2019
Last updated
9 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mastication in people with Nutrition and Mastication, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure of energy expenditure by Indirect calorimetry (time frame: 1 hour 30 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04050930.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.

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