AzTrials
AzTrials

AdiposityObVagueNCT06175988

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

An observational study of Adiposity and Food Preferences, run by Laval University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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"). Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Adiposity, Food Preferences, Eating Behavior
What is being tested?
Visceral adiposity
How many people
70 participants
Where
1 siteCanada
Study dates
11 Dec 2023to 30 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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).

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Sylvain Iceta, MD, PhD contact

+14186568711

equipe.iceta@criucpq.ulaval.ca

Canada1 site, 1 recruiting
  • IUCPQ

    Québec, Quebec

    Sylvain Iceta, 4186568711, equipe.iceta@criucpq.ulaval.ca

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read more

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.

Being tested
Visceral adiposity
Medical subject headings
Obesity, Food Preferences, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visceral adiposityOther

    Visceral adiposity assess by the visceral adiposity index

Study groups in NCT06175988
Study groupRoleWhat they receive
Visceral AdiposityNo 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.
Receives: Other: Visceral adiposity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. "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).

    Measured: Baseline

  2. 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).

    Measured: Baseline

  3. "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".

    Measured: Baseline

  4. "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".

    Measured: Baseline

  5. "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".

    Measured: Baseline

  6. "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".

    Measured: Baseline

  7. "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".

    Measured: Baseline

  8. "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".

    Measured: Baseline

  9. "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".

    Measured: Baseline

  10. "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".

    Measured: Baseline

  11. "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".

    Measured: Baseline

  12. "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".

    Measured: Baseline

  13. "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".

    Measured: Baseline

  14. "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".

    Measured: Baseline

Secondary outcomes (33)
  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: Baseline

  6. LF/HF ratio

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

    Measured: Baseline

  7. 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.

    Measured: Baseline

  8. 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.

    Measured: Baseline

  9. 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.

    Measured: Baseline

  10. 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.

    Measured: Baseline

  11. 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.

    Measured: Baseline

  12. 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.

    Measured: Baseline

  13. 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.

    Measured: Baseline

  14. 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.

    Measured: Baseline

  15. 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.

    Measured: Baseline

  16. 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.

    Measured: Baseline

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

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

    Measured: Baseline

  18. 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.

    Measured: Baseline

  19. 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.

    Measured: Baseline

  20. 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.

    Measured: Baseline

  21. 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.

    Measured: Baseline

  22. 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.

    Measured: Baseline

  23. 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.

    Measured: Baseline

  24. CCK fasting blood levels

    Fasting blood sample. (mmol/L)

    Measured: Baseline

  25. PYY fasting blood levels

    Fasting blood sample. (mmol/L)

    Measured: Baseline

  26. GLP-1 fasting blood levels

    Fasting blood sample. (mmol/L)

    Measured: Baseline

  27. Glicentine fasting blood levels

    Fasting blood sample. (mmol/L)

    Measured: Baseline

  28. Oxytomodulin fasting blood levels

    Fasting blood sample. (mmol/L)

    Measured: Baseline

  29. LPS fasting blood levels

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

    Measured: Baseline

  30. IL-6 fasting blood levels

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

    Measured: Baseline

  31. Fasting Glycemia

    Fasting blood sample. (mmol/L)

    Measured: Baseline

  32. Fasting Insulinemia

    Fasting blood sample. (pmol/L)

    Measured: Baseline

  33. 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)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2023
  2. Study start11 Dec 2023
  3. Primary completion30 Jul 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06175988
Sponsor's protocol ID
2024-4097, 22392
Acronym
ObVague
Status last verified
Oct 2024
First submitted
1 Dec 2023
Last updated
9 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Adiposity and Food Preferences, run by Laval University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sylvain Iceta, MD, PhD (+14186568711, equipe.iceta@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

"Taste Strips" total score (time frame: Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in