跳至主要内容
临床试验/NCT04050930
NCT04050930Unknown不适用

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

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年12月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
24
试验地点
1
主要终点
Measure of cardiac activity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Normal weight, normo-dented

Experimental

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

干预措施: Mastication (Other)

Obese, normo-dented

Experimental

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

干预措施: Mastication (Other)

结局指标

主要结局

Measure of cardiac activity

时间窗: 1 hour 30 minutes

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

Estimate of the hormonal response

时间窗: 1 hour 30 minutes

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.

Measure of energy expenditure by Indirect calorimetry

时间窗: 1 hour 30 minutes

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)

Measure of masticatory muscle activity

时间窗: 1 hour 30 minutes

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

次要结局

  • 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 masticatory muscle activity(1 hour 30 minutes)
  • cardiac activity while sleeping measured by electrocardiogram(8-10 hours (night))
  • cardiac activity (frequency analysis) while sleeping measured by electrocardiogram(8-10 hours (night))
  • global characterization of food choices(4 consecutive days)
  • effect of sensory information from oral cavity on hormonal response(1 hour 30 minutes)
  • global characterization of sport activity(4 consecutive days)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验