NCT06175988

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

December 11, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

1.6 years

First QC Date

December 1, 2023

Last Update Submit

October 7, 2024

Conditions

Outcome Measures

Primary Outcomes (14)

  • "Taste Strips" total score

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

    Baseline

  • TDI score, or "Sniffin Sticks" total score

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

    Baseline

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

    "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".

    Baseline

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

    "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".

    Baseline

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

    "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".

    Baseline

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

    "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".

    Baseline

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

    "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".

    Baseline

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

    "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".

    Baseline

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

    "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".

    Baseline

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

    "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".

    Baseline

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

    "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".

    Baseline

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

    "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".

    Baseline

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

    "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".

    Baseline

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

    "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".

    Baseline

Secondary Outcomes (33)

  • Standard deviation of the N-N interval (SDNN)

    Baseline

  • pNN50

    Baseline

  • Root mean square of successive N-N interval difference (RMSSD)

    Baseline

  • Low Frequency (LF)

    Baseline

  • High Frequency (HF)

    Baseline

  • +28 more secondary outcomes

Study Arms (1)

Visceral Adiposity

No intervention to be adminstrated. Participants will be considered based on their visceral adiposity (ctageorial and continous). Visceral adiposity index is computed with BMI, waist circumference, triglyceridemia, HDL-cholesterol levels, and biological sex.

Other: Visceral adiposity

Interventions

Visceral adiposity assess by the visceral adiposity index

Visceral Adiposity

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IUCPQ

Québec, Quebec, Canada

RECRUITING

MeSH Terms

Conditions

ObesityFood PreferencesFeeding Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBehavior, Animal

Central Study Contacts

Sylvain Iceta, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 1, 2023

First Posted

December 19, 2023

Study Start

December 11, 2023

Primary Completion

July 30, 2025

Study Completion

December 30, 2025

Last Updated

October 9, 2024

Record last verified: 2024-10

Locations