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

Eating Behavior Clinical Trial

— ObVague  

Official title:

Adiposité viscérale, Tonus Vagal et préférences Alimentaires : Une étude Pilote

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06175988
• Other study ID #: 2024-4097, 22392
• Status: Not yet recruiting
• Start date: December 11, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: Laval University
• Contact: Sylvain Iceta, MD, PhD
• Phone: +14186568711
• Email: equipe.iceta[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adiposity
• Eating Behavior
• Food Preferences
• Obesity

Intervention

Other:
• Visceral adiposity
Visceral adiposity assess by the visceral adiposity index

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"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
Primary	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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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
Primary	"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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Satiety volume as a percentage of total volume (Water Load Task)	Indicator of gastric interoceptive capacities obtained during the "Water Load Task".	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	CCK fasting blood levels	Fasting blood sample. (mmol/L)	Baseline
Secondary	PYY fasting blood levels	Fasting blood sample. (mmol/L)	Baseline
Secondary	GLP-1 fasting blood levels	Fasting blood sample. (mmol/L)	Baseline
Secondary	Glicentine fasting blood levels	Fasting blood sample. (mmol/L)	Baseline
Secondary	Oxytomodulin fasting blood levels	Fasting blood sample. (mmol/L)	Baseline
Secondary	LPS fasting blood levels	Associated with adipose tissue dysfunction. Fasting blood sample. (mmol/L)	Baseline
Secondary	IL-6 fasting blood levels	Associated with adipose tissue dysfunction. Fasting blood sample. (mmol/L)	Baseline
Secondary	Fasting Glycemia	Fasting blood sample. (mmol/L)	Baseline
Secondary	Fasting Insulinemia	Fasting blood sample. (pmol/L)	Baseline
Secondary	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