Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06175988

Visceral Adiposity, Vagal Tone and Food Preferences: a Pilot Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Adiposity Behavior Behavior, Animal Body Weight Eating Behavior Feeding Behavior Food Preferences Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Visceral adiposity

Other

Visceral adiposity assess by the visceral adiposity index

Primary outcomes

  1. "Taste Strips" total score

    Time frame: Baseline

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

  2. TDI score, or "Sniffin Sticks" total score

    Time frame: Baseline

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

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

    Time frame: 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".

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

    Time frame: 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".

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

    Time frame: 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".

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

    Time frame: 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".

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

    Time frame: 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".

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

    Time frame: 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".

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

    Time frame: 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".

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

    Time frame: 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".

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

    Time frame: 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".

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

    Time frame: 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".

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

    Time frame: 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".

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

    Time frame: 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".

Secondary outcomes

  1. Standard deviation of the N-N interval (SDNN)

    Time frame: Baseline

    Parameter of the heart rate variability, indirect indicator of the vagal tone (ms). Standard deviation of NN intervals. Measured using a 48 hours Holter monitor.

  2. pNN50

    Time frame: Baseline

    Parameter of the heart rate variability, indirect indicator of the vagal tone (%). Percentage of successive R-R intervals that differ by more than 50 ms. Measured using a 48 hours Holter monitor.

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

    Time frame: Baseline

    Parameter of the heart rate variability, indirect indicator of the vagal tone (ms). Root mean square of successive R-R interval differences. Measured using a 48 hours Holter monitor.

  4. Low Frequency (LF)

    Time frame: Baseline

    Parameter of the heart rate variability, indirect indicator of the vagal tone (ms²). Power spectral density of low frequencies. Measured using a 48 hours Holter monitor.

  5. High Frequency (HF)

    Time frame: Baseline

    Parameter of the heart rate variability, indirect indicator of the vagal tone (ms²). Power spectral density of high frequencies. Measured using a 48 hours Holter monitor.

  6. LF/HF ratio

    Time frame: Baseline

    Parameter of the heart rate variability, indirect indicator of the vagal tone (a.u.). Measured using a 48 hours Holter monitor.

  7. Sweet Perceived Intensity

    Time frame: Baseline

    Measured during the "Taste Strips" using "9 Likert scales" ranging from "no taste" to "intense" will be used. A score ranging from 1 to 9 will be calculated.

  8. Salty Perceived Intensity

    Time frame: Baseline

    Measured during the "Taste Strips" using "9 Likert scales" ranging from "no taste" to "intense" will be used. A score ranging from 1 to 9 will be calculated.

  9. Bitter Perceived Intensity

    Time frame: Baseline

    Measured during the "Taste Strips" using "9 Likert scales" ranging from "no taste" to "intense" will be used. A score ranging from 1 to 9 will be calculated.

  10. Sour Perceived Intensity

    Time frame: Baseline

    Measured during the "Taste Strips" using "9 Likert scales" ranging from "no taste" to "intense" will be used. A score ranging from 1 to 9 will be calculated.

  11. Sweet Perceived Appreciation

    Time frame: Baseline

    Measured during the "Taste Strips" using "9 Likert scales" ranging from "extremely unpleasant" to "extremely pleasant" will be used. A score ranging from 1 to 9 will be calculated.

  12. Salty Perceived Appreciation

    Time frame: Baseline

    Measured during the "Taste Strips" using "9 Likert scales" ranging from "extremely unpleasant" to "extremely pleasant" will be used. A score ranging from 1 to 9 will be calculated.

  13. Bitter Perceived Appreciation

    Time frame: Baseline

    Measured during the "Taste Strips" using "9 Likert scales" ranging from "extremely unpleasant" to "extremely pleasant" will be used. A score ranging from 1 to 9 will be calculated.

  14. Sour Perceived Appreciation

    Time frame: Baseline

    Measured during the "Taste Strips" using "9 Likert scales" ranging from "extremely unpleasant" to "extremely pleasant" will be used. A score ranging from 1 to 9 will be calculated.

  15. Odors Perceived Intensity

    Time frame: Baseline

    Measured during the "Sniffin Sticks" (identification test) using "9 Likert scales" ranging from "no odor" to "intense" will be used. A score ranging from 1 to 9 will be calculated.

  16. Odors Perceived Appreciation

    Time frame: Baseline

    Measured during the "Sniffin Sticks" (identification test) using "9 Likert scales" ranging from "extremely unpleasant" to "extremely pleasant" will be used. A score ranging from 1 to 9 will be calculated.

  17. Satiety volume as a percentage of total volume (Water Load Task)

    Time frame: Baseline

    Indicator of gastric interoceptive capacities obtained during the "Water Load Task".

  18. Beck Depression Inventory II (BDI-II) score

    Time frame: Baseline

    Evaluates severity of depressive symptoms using a validated questionnaire. Minimum score : 0; Maximun score : 63; Higher scores mean a worse outcome.

  19. State-Trait Anxiety Inventory (STAI) score

    Time frame: Baseline

    Evaluates severity of anxiety symptoms using a validated questionnaire. The questionnaire includes two scales (20 items) consisting of a total of 40 questions. For each scale the minimum score is 0 and the maximun score is 80. Higher scores mean a worse outcome.

  20. Eating Disorder Examination Questionnaire (EDE-Q) score

    Time frame: Baseline

    Evaluates presence of eating disorders using a validated questionnaire. The measure provides four attitudinal subscale scores: Restraint (5 items), Eating Concern (5 items), Shape Concern (8 items), and Weight Concern (5 items). An overall Global score is the mean of the four subscale scores. Responses are on a 7-point ordinal response; minimum score : 0, maximun score: 6; higher scores mean a worse outcome.

  21. Food Craving Trait Questionnaire (FCQ T) score

    Time frame: Baseline

    Evaluates severity of cravings using a validated questionnaire. Minimum : 39; Maximum : 234; Higher scores mean a worse outcome.

  22. Food Craving State Questionnaire (FCQ S) score

    Time frame: Baseline

    Evaluates severity of cravings using a validated questionnaire. Minimum : 15; Maximum : 75; Higher scores mean a worse outcome.

  23. Body Awareness Questionnaire (BAQ) score

    Time frame: Baseline

    Evaluates attention to intern signals (interoception) using a validated questionnaire. Minimum score: 18; Maximun score: 126; Higher scores mean a better outcome.

  24. CCK fasting blood levels

    Time frame: Baseline

    Fasting blood sample. (mmol/L)

  25. PYY fasting blood levels

    Time frame: Baseline

    Fasting blood sample. (mmol/L)

  26. GLP-1 fasting blood levels

    Time frame: Baseline

    Fasting blood sample. (mmol/L)

  27. Glicentine fasting blood levels

    Time frame: Baseline

    Fasting blood sample. (mmol/L)

  28. Oxytomodulin fasting blood levels

    Time frame: Baseline

    Fasting blood sample. (mmol/L)

  29. LPS fasting blood levels

    Time frame: Baseline

    Associated with adipose tissue dysfunction. Fasting blood sample. (mmol/L)

  30. IL-6 fasting blood levels

    Time frame: Baseline

    Associated with adipose tissue dysfunction. Fasting blood sample. (mmol/L)

  31. Fasting Glycemia

    Time frame: Baseline

    Fasting blood sample. (mmol/L)

  32. Fasting Insulinemia

    Time frame: Baseline

    Fasting blood sample. (pmol/L)

  33. Appetite scores

    Time frame: Baseline

    Calculated on the basis of a rating from 0 to 10 for each of the following parameters: sensation of hunger, desire to eat, satiation and prospective consumption. These ratings will be estimated using 100 mm-long visual analog scales annotated with "not at all" and "extremely", on the left and right of the scale respectively, to answer the following questions: "At the moment, how hungry are you?", "At the moment, how hungry are you?", "At the moment, how hungry are you?" and "At the moment, how hungry do you think you are?".

    Before each tests on the exploration day (taste, olfaction, LFPQ, Water Load Task, questionnaires)

Study contacts

Contact information is provided by the study sponsor or research team.

Sylvain Iceta, MD, PhD

CONTACT

[email protected]

+14186568711

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Acronym: ObVague

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2023
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.