Clinical trial NCT06175988: Visceral Adiposity, Vagal Tone and Food Preferences: a Pilot Study
Official title: Adiposité Viscérale, Tonus Vagal Et Préférences Alimentaires : Une Étude Pilote
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adiposity
Food Preferences
Eating Behavior
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult men and women aged between 18 and 45 will be selected. This age limitation applied to both sexes will limit the risk of including post-menopausal women, without unbalancing the average age between the biological sexes. We will meet participants during the follicular phase of their cycle (beginning on the first day of menstruation and ending at ovulation).

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: "Taste Strips" total score
timeFrame: Baseline
measure: TDI score, or "Sniffin Sticks" total score
timeFrame: Baseline
measure: "Explicit liking" score for high-fat/sweet foods
timeFrame: Baseline
measure: "Explicit liking" score for high-fat/savoury foods
timeFrame: Baseline
measure: "Explicit liking" score for low-fat/high-sweet foods
timeFrame: Baseline
measure: "Explicit liking" score for low-fat/savoury foods
timeFrame: Baseline
measure: "Explicit wanting" score for high-fat/sweet foods
timeFrame: Baseline
measure: "Explicit wanting" score for high-fat/savoury foods
timeFrame: Baseline
measure: "Explicit wanting" score for low-fat/sweet foods
timeFrame: Baseline
measure: "Explicit wanting" score for low-fat/savoury foods
timeFrame: Baseline
measure: "Implicit wanting" score for high-fat/sweet foods
timeFrame: Baseline
measure: "Implicit wanting" score for high-fat/savoury foods
timeFrame: Baseline
measure: "Implicit wanting" score for low-fat/sweet foods
timeFrame: Baseline
measure: "Implicit wanting" score for low-fat/savoury foods
timeFrame: Baseline
Secondary outcomes:
measure: Standard deviation of the N-N interval (SDNN)
timeFrame: Baseline
measure: pNN50
timeFrame: Baseline
measure: Root mean square of successive N-N interval difference (RMSSD)
timeFrame: Baseline
measure: Low Frequency (LF)
timeFrame: Baseline
measure: High Frequency (HF)
timeFrame: Baseline
measure: LF/HF ratio
timeFrame: Baseline
measure: Sweet Perceived Intensity
timeFrame: Baseline
measure: Salty Perceived Intensity
timeFrame: Baseline
measure: Bitter Perceived Intensity
timeFrame: Baseline
measure: Sour Perceived Intensity
timeFrame: Baseline
measure: Sweet Perceived Appreciation
timeFrame: Baseline
measure: Salty Perceived Appreciation
timeFrame: Baseline
measure: Bitter Perceived Appreciation
timeFrame: Baseline
measure: Sour Perceived Appreciation
timeFrame: Baseline
measure: Odors Perceived Intensity
timeFrame: Baseline
measure: Odors Perceived Appreciation
timeFrame: Baseline
measure: Satiety volume as a percentage of total volume (Water Load Task)
timeFrame: Baseline
measure: Beck Depression Inventory II (BDI-II) score
timeFrame: Baseline
measure: State-Trait Anxiety Inventory (STAI) score
timeFrame: Baseline
measure: Eating Disorder Examination Questionnaire (EDE-Q) score
timeFrame: Baseline
measure: Food Craving Trait Questionnaire (FCQ T) score
timeFrame: Baseline
measure: Food Craving State Questionnaire (FCQ S) score
timeFrame: Baseline
measure: Body Awareness Questionnaire (BAQ) score
timeFrame: Baseline
measure: CCK fasting blood levels
timeFrame: Baseline
measure: PYY fasting blood levels
timeFrame: Baseline
measure: GLP-1 fasting blood levels
timeFrame: Baseline
measure: Glicentine fasting blood levels
timeFrame: Baseline
measure: Oxytomodulin fasting blood levels
timeFrame: Baseline
measure: LPS fasting blood levels
timeFrame: Baseline
measure: IL-6 fasting blood levels
timeFrame: Baseline
measure: Fasting Glycemia
timeFrame: Baseline
measure: Fasting Insulinemia
timeFrame: Baseline
measure: Appetite scores
timeFrame: Baseline
Other outcomes:
Locations:
city: Québec
country: Canada
facility: IUCPQ
state: Quebec
Study officials:
References: