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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Food Preferences; Adiposity; Eating Behavior
• Intervention / Treatment: Other: Visceral adiposity

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Sylvain Iceta, MD, PhD; Phone Number: +14186568711; Email: equipe.iceta@criucpq.ulaval.ca

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada
      • Recruiting
      • IUCPQ
      • Contact: Sylvain Iceta; Phone Number: 4186568711; Email: equipe.iceta@criucpq.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Visceral adiposity assess by the visceral adiposity index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard deviation of the N-N interval (SDNN)	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.	Baseline
pNN50	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.	Baseline
Root mean square of successive N-N interval difference (RMSSD)	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.	Baseline
Low Frequency (LF)	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.	Baseline
High Frequency (HF)	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.	Baseline
LF/HF ratio	Parameter of the heart rate variability, indirect indicator of the vagal tone (a.u.). Measured using a 48 hours Holter monitor.	Baseline
Sweet Perceived Intensity	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.	Baseline
Salty Perceived Intensity	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.	Baseline
Bitter Perceived Intensity	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.	Baseline
Sour Perceived Intensity	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.	Baseline
Sweet Perceived Appreciation	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.	Baseline
Salty Perceived Appreciation	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.	Baseline
Bitter Perceived Appreciation	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.	Baseline
Sour Perceived Appreciation	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.	Baseline
Odors Perceived Intensity	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.	Baseline
Odors Perceived Appreciation	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.	Baseline
Satiety volume as a percentage of total volume (Water Load Task)	Indicator of gastric interoceptive capacities obtained during the "Water Load Task".	Baseline
Beck Depression Inventory II (BDI-II) score	Evaluates severity of depressive symptoms using a validated questionnaire. Minimum score : 0; Maximun score : 63; Higher scores mean a worse outcome.	Baseline
State-Trait Anxiety Inventory (STAI) score	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.	Baseline
Eating Disorder Examination Questionnaire (EDE-Q) score	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.	Baseline
Food Craving Trait Questionnaire (FCQ T) score	Evaluates severity of cravings using a validated questionnaire. Minimum : 39; Maximum : 234; Higher scores mean a worse outcome.	Baseline
Food Craving State Questionnaire (FCQ S) score	Evaluates severity of cravings using a validated questionnaire. Minimum : 15; Maximum : 75; Higher scores mean a worse outcome.	Baseline
Body Awareness Questionnaire (BAQ) score	Evaluates attention to intern signals (interoception) using a validated questionnaire. Minimum score: 18; Maximun score: 126; Higher scores mean a better outcome.	Baseline
CCK fasting blood levels	Fasting blood sample. (mmol/L)	Baseline
PYY fasting blood levels	Fasting blood sample. (mmol/L)	Baseline
GLP-1 fasting blood levels	Fasting blood sample. (mmol/L)	Baseline
Glicentine fasting blood levels	Fasting blood sample. (mmol/L)	Baseline
Oxytomodulin fasting blood levels	Fasting blood sample. (mmol/L)	Baseline
LPS fasting blood levels	Associated with adipose tissue dysfunction. Fasting blood sample. (mmol/L)	Baseline
IL-6 fasting blood levels	Associated with adipose tissue dysfunction. Fasting blood sample. (mmol/L)	Baseline
Fasting Glycemia	Fasting blood sample. (mmol/L)	Baseline
Fasting Insulinemia	Fasting blood sample. (pmol/L)	Baseline
Appetite scores	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)	Baseline

Collaborators and Investigators

• Sponsor: Laval University

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2023
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 19, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 2024-4097, 22392

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No