SENSILINS: Impact of Cephalic Phase Insulin Release Induced by an Environmental Food Odor Stimulu… (NCT07638111) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
SENSILINS: Impact of Cephalic Phase Insulin Release Induced by an Environmental Food Odor Stimulus on Glucose Homeostasis According to Insulin Sensitivity Level
France20 participantsStarted 2026-06
Plain-language summary
This single-center, randomized, single-blind, 2-period crossover interventional study will evaluate whether exposure to a pleasant food odor 10 minutes before a 75 g oral glucose tolerance test (OGTT) modifies glucose homeostasis in adults with different metabolic phenotypes. Participants will undergo two experimental conditions in random order: food odor stimulation and control condition without odor, separated by a 4-week washout. The main objective is to quantify the within-subject effect of food odor stimulation on the incremental area under the glucose curve (iAUC) from 0 to 120 minutes during OGTT and to assess whether this effect differs according to metabolic status. Two predefined groups will be enrolled: adults without overweight and without insulin resistance, and adults with class I obesity and low-to-moderate insulin resistance. Secondary objectives include characterization of cephalic phase insulin release (CPIR), C-peptide and GLP-1 responses, glycemic kinetics, associations between CPIR and metabolic responses, and participant acceptability of the test environment and olfactory stimulation. A plasma biobank will be constituted from part of the collected samples for future research.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Age 18 to 50 years inclusive
* Stable body weight during the previous 3 months (±5% of total body weight)
* Willing to comply with the full study protocol
* Sedentary lifestyle or stable regular physical activity, with agreement to keep this unchanged throughout the study
* Able to understand study information, read and write French, and provide written informed consent
* Affiliated with a social security scheme or equivalent
* Non-smoker and non-vaper
* Willing not to take dietary supplements, probiotics, prebiotics, or laxatives for 10 days before each visit
* For women of childbearing potential: negative serum pregnancy test; not pregnant and not breastfeeding
* Mean score between 1 and 2 on the 3 specific CiTAS questionnaire statements used as inclusion criteria
* ETOC flash olfactory screening: able to detect the odor-containing vial among 4 presented vials for all 7 odors tested
* Able to identify the madeleine odor used in the study
* Rated pleasantness/appetence of the madeleine odor above 1/9
* For the no-overweight group: BMI 19 to \<25 kg/m² and HOMA-IR \<1.7
* For the obesity group: BMI 30 to \<35 kg/m² and low-to-moderate insulin resistance based on HOMA-IR \[protocol inconsistency to resolve; see note below\]
Exclusion Criteria
* Unstable medical or psychological conditions that could impair compliance, safety, or study participation in the investigator's judgment
* Alcohol consumption \>30 g/day, or established abuse/dependence on anothe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Within-subject difference in glucose incremental area under the curve (iAUC) from 0 to 120 minutes during OGTT
Timeframe: During each experimental visit, from 0 to 120 minutes after ingestion of the 75 g oral glucose load