跳至主要内容
临床试验/NCT06175988
NCT06175988招募中不适用

Adiposité Viscérale, Tonus Vagal Et Préférences Alimentaires : Une Étude Pilote

Laval University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年12月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
"Explicit wanting" score for low-fat/savoury foods

研究概览

简要总结

Food preferences are defined by a number of measurable parameters, such as per se food choices, sensitivity of taste and olfactory sensory perceptions, hedonic appreciation of foods ("liking") and motivation to consume them ("wanting"). These food preferences are fundamental to the quality of food intake, and are therefore a key factor influencing weight loss or maintenance of a stable weight. Obesity is also associated with reduced sensory sensitivity to taste and smell, as well as disturbances in the responses of the food reward system.

However, the internal, or physiological, mechanisms impacting these food preferences are still poorly understood. To date, several studies seem to point to the role of body composition, in particular visceral adiposity, or adiposity surrounding the digestive organs. Indeed, a high level of visceral adiposity is associated with the onset of numerous cardiometabolic disorders, but also with altered sensory perceptions.

This relationship could be mediated by the vagus nerve, which connects the digestive organs to the brain, enabling the perception of internal signals sent by the body, such as feelings of hunger or satiety. Low vagal activity is associated not only with abdominal obesity, but also with reduced sensory sensitivity to taste and smell, and changes in food choices in favor of energy-dense foods (rich in fats and/or sugars). Electrical stimulation of the vagus nerve is now recognized as a possible treatment for morbid obesity in the USA, but the mechanisms leading to the expected weight loss are still debated. Similarly, an increase in vagal tone has been found in patients who have undergone bariatric surgery for the treatment of severe complicated to morbid obesity, in parallel with sensory disturbances.

The overall aim of this project is to explore and confirm the relationship between visceral adiposity and various food preference parameters, such as olfactory and gustatory perceptions and reward system responses, involving liking and wanting certain foods and associated behaviors. This project also aims to shed light on the possible mediation of the vagus nerve in this relationship.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Have a BMI between 18.5 and 35 kg/m²;
  • French-speaking;
  • Be able to travel to the Research Center of the Institut Universitaire de Cardiologie et Pneumologie de Québec for an investigative visit.

排除标准

  • Smokers ;
  • Women who know they are pregnant, breastfeeding or menopausal;
  • Who have been diagnosed with type I or type II diabetes;
  • Having undergone bariatric surgery or obesity medication (GLP1 analogue, naltrexon-bupropion combination, etc.);
  • Presenting an allergy or intolerance to one of the products used in the sensory tests (taste test: sucrose, sodium chloride, citric acid, quinine hydrochloride dihydrate; olfactory test: citrus, lemongrass, cinnamon, mint, peppermint, banana, anise, turpentine, garlic, coffee, apple, clove, pineapple, rose, geranium, eucalyptus, wormwood, fennel, caraway, leather, n-butanol, linalool, pyridine, diethyl phthalate, propylene glycol);
  • Have a history of pathologies which, in the investigator's opinion, could interfere with the study criteria, such as ENT, neurological, upper digestive or cardiac pathologies;
  • Receiving long-term pharmacological treatment, in particular antidepressants, antipsychotics, benzodiazepines, beta-blockers, etc. ;
  • Presenting or having presented in the last 6 months a thymic episode such as depression, bipolar disorder, etc. ;
  • Wearing a cardiostimulator (pacemaker);
  • Minors or adults under guardianship.

结局指标

主要结局

"Explicit wanting" score for low-fat/savoury foods

时间窗: Baseline

"Explicit wanting" will be measured using visual analog scales anchored at each end with "not at all" and "extremely" to answer the question "How much would like to eat some of this food now?" while seeing pictures of food items. (/100) The task used is the "Leeds Food Preference Questionnaire".

TDI score, or "Sniffin Sticks" total score

时间窗: Baseline

Olfaction score based on odor detection (Threshold), Discrimination, and Identification (/48). The test used is "Sniffin Sticks" (ODOFIN, Burghart Messtechnik GmbH, Holm, Germany).

"Explicit liking" score for high-fat/sweet foods

时间窗: Baseline

"Explicit liking" will be measured using visual analog scales anchored at each end with "not at all" and "extremely" to answer the question "How pleasant would it be to taste this food now?" while seeing pictures of food items. (/100) The task used is the "Leeds Food Preference Questionnaire".

"Explicit liking" score for low-fat/high-sweet foods

时间窗: Baseline

"Explicit liking" will be measured using visual analog scales anchored at each end with "not at all" and "extremely" to answer the question "How pleasant would it be to taste this food now?" while seeing pictures of food items. (/100) The task used is the "Leeds Food Preference Questionnaire".

"Explicit liking" score for low-fat/savoury foods

时间窗: Baseline

"Explicit liking" will be measured using visual analog scales anchored at each end with "not at all" and "extremely" to answer the question "How pleasant would it be to taste this food now?" while seeing pictures of food items. (/100) The task used is the "Leeds Food Preference Questionnaire".

"Explicit liking" score for high-fat/savoury foods

时间窗: Baseline

"Explicit liking" will be measured using visual analog scales anchored at each end with "not at all" and "extremely" to answer the question "How pleasant would it be to taste this food now?" while seeing pictures of food items. (/100) The task used is the "Leeds Food Preference Questionnaire".

"Explicit wanting" score for low-fat/sweet foods

时间窗: Baseline

"Explicit wanting" will be measured using visual analog scales anchored at each end with "not at all" and "extremely" to answer the question "How much would like to eat some of this food now?" while seeing pictures of food items. (/100) The task used is the "Leeds Food Preference Questionnaire".

"Implicit wanting" score for high-fat/savoury foods

时间窗: Baseline

"Implicit wanting" will be calculated using a forced-choice task. It involves the presentation of successive pairs of food pictures, each pair being the object of a spontaneous preferential choice by the volunteer. A score is calculated from the frequency of choice and non-choice of said category and the reaction time of the participants. This score ranges from -100 to 100 and is interpreted in relation to the scores for the other food categories assessed in the task. A positive score indicates that the food category under consideration was chosen more often and more quickly than the others. A negative score indicates the opposite. The task used is the "Leeds Food Preference Questionnaire".

"Taste Strips" total score

时间窗: Baseline

Taste identification score for sweet, salty, bitter, and sour (/16). The test used is "Taste Strips" (ODOFIN, Burghart Messtechnik GmbH, Holm, Germany).

"Explicit wanting" score for high-fat/sweet foods

时间窗: Baseline

"Explicit wanting" will be measured using visual analog scales anchored at each end with "not at all" and "extremely" to answer the question "How much would like to eat some of this food now?" while seeing pictures of food items. (/100) The task used is the "Leeds Food Preference Questionnaire".

"Explicit wanting" score for high-fat/savoury foods

时间窗: Baseline

"Explicit wanting" will be measured using visual analog scales anchored at each end with "not at all" and "extremely" to answer the question "How much would like to eat some of this food now?" while seeing pictures of food items. (/100) The task used is the "Leeds Food Preference Questionnaire".

"Implicit wanting" score for high-fat/sweet foods

时间窗: Baseline

"Implicit wanting" will be calculated using a forced-choice task. It involves the presentation of successive pairs of food pictures, each pair being the object of a spontaneous preferential choice by the volunteer. A score is calculated from the frequency of choice and non-choice of said category and the reaction time of the participants. This score ranges from -100 to 100 and is interpreted in relation to the scores for the other food categories assessed in the task. A positive score indicates that the food category under consideration was chosen more often and more quickly than the others. A negative score indicates the opposite. The task used is the "Leeds Food Preference Questionnaire".

"Implicit wanting" score for low-fat/sweet foods

时间窗: Baseline

"Implicit wanting" will be calculated using a forced-choice task. It involves the presentation of successive pairs of food pictures, each pair being the object of a spontaneous preferential choice by the volunteer. A score is calculated from the frequency of choice and non-choice of said category and the reaction time of the participants. This score ranges from -100 to 100 and is interpreted in relation to the scores for the other food categories assessed in the task. A positive score indicates that the food category under consideration was chosen more often and more quickly than the others. A negative score indicates the opposite. The task used is the "Leeds Food Preference Questionnaire".

"Implicit wanting" score for low-fat/savoury foods

时间窗: Baseline

"Implicit wanting" will be calculated using a forced-choice task. It involves the presentation of successive pairs of food pictures, each pair being the object of a spontaneous preferential choice by the volunteer. A score is calculated from the frequency of choice and non-choice of said category and the reaction time of the participants. This score ranges from -100 to 100 and is interpreted in relation to the scores for the other food categories assessed in the task. A positive score indicates that the food category under consideration was chosen more often and more quickly than the others. A negative score indicates the opposite. The task used is the "Leeds Food Preference Questionnaire".

次要结局

  • Fasting Glycemia(Baseline)
  • LPS fasting blood levels(Baseline)
  • IL-6 fasting blood levels(Baseline)
  • Standard deviation of the N-N interval (SDNN)(Baseline)
  • Satiety volume as a percentage of total volume (Water Load Task)(Baseline)
  • CCK fasting blood levels(Baseline)
  • Fasting Insulinemia(Baseline)
  • Root mean square of successive N-N interval difference (RMSSD)(Baseline)
  • High Frequency (HF)(Baseline)
  • Sweet Perceived Intensity(Baseline)
  • Bitter Perceived Intensity(Baseline)
  • Sour Perceived Intensity(Baseline)
  • Sweet Perceived Appreciation(Baseline)
  • Salty Perceived Appreciation(Baseline)
  • Sour Perceived Appreciation(Baseline)
  • Odors Perceived Appreciation(Baseline)
  • Food Craving Trait Questionnaire (FCQ T) score(Baseline)
  • PYY fasting blood levels(Baseline)
  • LF/HF ratio(Baseline)
  • Odors Perceived Intensity(Baseline)
  • Eating Disorder Examination Questionnaire (EDE-Q) score(Baseline)
  • Food Craving State Questionnaire (FCQ S) score(Baseline)
  • Body Awareness Questionnaire (BAQ) score(Baseline)
  • GLP-1 fasting blood levels(Baseline)
  • Glicentine fasting blood levels(Baseline)
  • pNN50(Baseline)
  • Low Frequency (LF)(Baseline)
  • Salty Perceived Intensity(Baseline)
  • Bitter Perceived Appreciation(Baseline)
  • Beck Depression Inventory II (BDI-II) score(Baseline)
  • State-Trait Anxiety Inventory (STAI) score(Baseline)
  • Oxytomodulin fasting blood levels(Baseline)
  • Appetite scores(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvain Iceta

Principal Investigator

Laval University

研究点 (1)

Loading locations...

相似试验

Visceral Adiposity, Vagal Tone and Food Preferences:... | 临床试验