Obesity & OverweightSENSILNSNCT07638111
SENSILINS: Impact of Cephalic Phase Insulin Release Induced by an Environmental Food Odor Stimulus on Glucose Homeostasis According to Insulin Sensitivity Level
A study testing Pleasant Food Odor Stimulation in people with Obesity & Overweight and Insulin Resistance Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Insulin Resistance Syndrome
- What is being tested?
- Pleasant Food Odor Stimulation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 15Show fewer
- 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]
Who cannot join
- 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 another drug
- Ongoing exclusion period from another study listed in the national volunteer file
- Legal protection measure (guardianship/curatorship)
- Deprivation of liberty by judicial or administrative decision
- Exceeded annual compensation limit for research participation
Show all 24Show fewer
- Lack of valid required health documentation in the event of exceptional governmental epidemic measures
- Blood donation within 2 months before inclusion visit
- Limited venous access making repeated blood sampling/catheter placement difficult
- Current or permanent anosmia or olfactory disorder
- Type 1 or type 2 diabetes, treated or untreated
- History of gestational diabetes
- Known or treated hypertension
- Blood pressure >160 [unit missing; likely mmHg systolic threshold]
- Dyslipidemia, treated or untreated
- Triglycerides >3 mmol/L
- Allergic rhinitis
- Nasosinusal polyposis
- History of intestinal or abdominal surgery except appendectomy or simple hernia repair
- History of ENT or neurological surgery
- Severe eating disorder (for example anorexia, bulimia, binge-eating disorder, night eating)
- Any pathology detected on clinical examination or medical interview judged by the investigator to interfere with study endpoints or participant safety
- Any biological abnormality judged by the investigator to interfere with study endpoints or participant safety
- Use of treatments likely to interfere with study measurements, for example antidepressants, antiepileptics, neuroleptics, CPAP treatment for sleep apnea, nasal spray medications, or anti-obesity drug treatment, according to investigator judgment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre de Recherche en Nutrition Humaine Rhône-Alpes, Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Anne Laure CASTELL, MD, +33 4 78 86 19 72 ext. +33, anne-laure.castell@chu-lyon.fr
Nathalie Feugier-Favier, MD, +33 4 78 86 29 54 ext. +33, nathalie.feugier@chu-lyon.fr
About this study
Official title: Impact of Cephalic Phase Insulin Release Induced by an Environmental Food Odor Stimulus on Glucose Homeostasis According to Insulin Sensitivity Level
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.
Read the detailed description
Recent experimental and translational data suggest that olfactory cues may contribute to metabolic regulation through anticipatory cephalic phase responses. Cephalic phase insulin release (CPIR) is an early preabsorptive insulin response triggered by sensory food-related stimuli before nutrient absorption. Preclinical data generated by the study team suggest that food-odor-induced CPIR involves an olfactory bulb-pancreas axis and may be altered in obesity. The present study is designed to investigate, in humans, whether a pleasant appetitive food odor delivered before glucose ingestion can induce measurable CPIR and improve post-load glucose handling.
The study uses a randomized AB/BA crossover design with two experimental visits after screening and inclusion. During one visit, participants are exposed to prerecorded food odor diffusion using a ScentRealm collar starting at T-10 minutes before ingestion of a 75 g glucose solution at T0. During the control visit, the same testing environment is maintained without odor stimulation. Serial blood sampling is performed before and after glucose ingestion to characterize glucose, insulin, C-peptide, and GLP-1 kinetics. The washout period is 4 weeks (±3 days), partly to align visits within the same menstrual cycle phase in women when applicable. The trial includes 20 adults aged 18 to 50 years: 10 without overweight and insulin-sensitive, and 10 with obesity and low-to-moderate insulin resistance defined using HOMA-IR.
- Conditions
- Obesity & Overweight, Insulin Resistance Syndrome
- Being tested
- Pleasant Food Odor Stimulation, Control Environmental Condition
- Keywords
- Glucose Homeostasis, Cephalic Phase Insulin Release, Food odor, Olfaction, Oral glucose tolerance test, Insulin secretion, GLP-1
- Medical subject headings
- Obesity, Overweight, Metabolic Syndrome, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleasant Food Odor StimulationBehavioural
Exposure to an experimentally selected appetitive food odor (madeleine odor) delivered using a programmable ScentRealm collar in a standardized test room beginning at T-10 minutes before OGTT.
Control Environmental ConditionBehavioural
Standardized testing environment identical to the experimental visit but without diffusion of the appetitive food odor.
| Study group | Role | What they receive |
|---|---|---|
| Food Odor Stimulation | Active comparator | Participants are exposed to a pleasant appetitive food odor delivered through a ScentRealm collar beginning 10 minutes before ingestion of a 75 g oral glucose load and continuing according to a prerecorded sequence during the metabolic test visit. Receives: Behavioral: Pleasant Food Odor Stimulation; Behavioral: Control Environmental Condition |
| Control Condition | Placebo comparator | Participants undergo the same standardized metabolic test visit and OGTT procedures in the same test environment without food odor stimulation. Receives: Behavioral: Pleasant Food Odor Stimulation; Behavioral: Control Environmental Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-subject difference in glucose incremental area under the curve (iAUC) from 0 to 120 minutes during OGTT
Primary endpoint is the mean within-subject difference between food odor and control conditions in glucose incremental area under the curve from 0 to 120 minutes after oral glucose ingestion. Glucose iAUC will be calculated using the trapezoidal method, baseline-adjusted to glucose at T0. The main analysis will also assess the interaction between condition (odor vs control) and metabolic status (no overweight/insulin-sensitive vs obesity with low-to-moderate insulin resistance). Unit should be specified in the statistical analysis plan according to assay reporting (for example mmol/L×min or mg/dL×min).
Measured: During each experimental visit, from 0 to 120 minutes after ingestion of the 75 g oral glucose load
Secondary outcomes (37)
Preabsorptive and early post-ingestion insulin iAUC as a measure of cephalic phase insulin release
Incremental area under the curve for insulin during the pre-ingestion and early post-ingestion period (0 to 15 minutes), compared by condition and metabolic status. Additional CPIR-related metrics include latency, peak concentration, slope, and percentage of responders. Unit to specify according to assay output (for example µIU/mL×min or pmol/L×min).
Measured: From pre-OGTT odor exposure through 15 minutes after glucose ingestion during each experimental visit
Preabsorptive and early post-ingestion C-peptide iAUC
Incremental area under the curve for C-peptide during the pre-ingestion and early post-ingestion period (0 to 15 minutes), compared by condition and metabolic status. Additional metrics include latency, peak concentration, slope, and percentage of responders. Unit to specify according to assay output.
Measured: From pre-OGTT odor exposure through 15 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - Δmax
Effect of condition and metabolic status on glycemic maximum change from baseline (Δmax)
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - Time to peak
Effect of condition and metabolic status on the necessary amount of time to reach glycemic peak in minutes
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - Growth curve slope
Effect of condition and metabolic status on the slope of the glycemic growth curve from baseline
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - Decay curve slope
Effect of condition and metabolic status on the slope of the glycemic decay curve from the maximum (peak)
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - ultradian oscillation indices
Effect of condition and metabolic status on ultradian oscillation indices
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - iAUC (0 to 120 min)
Effect of condition and metabolic status on Incremental Area Under the Curve (IAUC) from 0 to 120 min for glucose
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - early glucose iAUC (0-30min)
Effect of condition and metabolic status on glucose Incremental Area Under the Curve (IAUC) from 0 to 30 min
Measured: From 0 to 30 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - late glucose iAUC (30-120 min)
Effect of condition and metabolic status on glucose Incremental Area Under the Curve (IAUC) from 30 to 120 min
Measured: From 30 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - iAUC (0-120 min)
Total Incremental Area Under the Curve (iAUC) from 0 to 120 minutes
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - iAUC (0-30min)
Insulin Incremental Area Under the Curve (IAUC) from 0 to 30 min
Measured: From 0 to 30 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - iAUC (30-120min)
Insulin Incremental Area Under the Curve (IAUC) from 30 to 120 min
Measured: From 30 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - Δmax
The value of the maximum (peak) of the curve relative to the baseline value for insulin
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - Time to peak
Necessary amount of time for insulin to reach peak in minutes
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - Growth curve slope
Slope of the insulin growth curve from baseline
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - Decay curve slope
Slope of the insulin decay curve from the maximum (peak)
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - iAUC (0-120min)
C-peptide Incremental Area Under the Curve (IAUC) from 0 to 120 min
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - iAUC (0-30min)
C-peptide Incremental Area Under the Curve (IAUC) from 0 to 30 min
Measured: From 0 to 30 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - iAUC (30-120min)
C-peptide Incremental Area Under the Curve (IAUC) from 30 to 120 min
Measured: From 30 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - Δmax
The value of the maximum (peak) of the curve relative to the baseline value for C-peptide
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - Time to peak
Necessary amount of time for C-peptide to reach peak in minutes
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - Growth curve slope
Slope of the C-peptide growth curve from baseline
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - Decay curve slope
Slope of the C-peptide decay curve from the maximum (peak)
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - iAUC (0-120min)
GLP1 Incremental Area Under the Curve (IAUC) from 0 to 120 min
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - iAUC (0-30min)
GLP-1 Incremental Area Under the Curve (IAUC) from 0 to 30 min
Measured: From 0 to 30 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - iAUC (30-120min)
GLP-1 Incremental Area Under the Curve (IAUC) from 30 to 120 min
Measured: From 30 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - Δmax
The value of the maximum (peak) of the curve relative to the baseline value for GLP-1
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - Time to peak
Necessary amount of time for GLP-1 to reach peak in minutes
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - Growth curve slope
Slope of the GLP-1 growth curve from baseline
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - Decay curve slope
Slope of the GLP-1 decay curve from the maximum (peak)
Measured: From 0 to 120 minutes after glucose ingestion during each experimental visit
Correlation between CPIR characteristics and metabolic/hormonal responses
Correlations between CPIR features and subsequent glucose response during OGTT (including glucose iAUC 0-120 and early/late components) and hormonal quantitative/kinetic responses, including assessment of interaction with metabolic status.
Measured: Assessed using measurements collected during each experimental visit up to 120 minutes after glucose ingestion
Participant-rated appreciation of the experimental odor
Appreciation of the experimental odor and related emotions assessed using Likert scales at the end of the odor visit, with comparison by condition and metabolic status where applicable. Exact scale range and anchor wording are not provided in the available protocol text.
Measured: Week 2 ; Week 4
Participant-rated acceptability of the test environment - Temperature
Acceptability and appreciation of the temperature of the environment assessed using Likert scales and free-text fields. Comparison by condition and metabolic status. Scale range should be entered exactly as used in source questionnaires.
Measured: Week 2 ; Week 4
Participant-rated acceptability of the test environment - Lighting
Acceptability and appreciation of the lighting of the environment assessed using Likert scales and free-text fields. Comparison by condition and metabolic status. Scale range should be entered exactly as used in source questionnaires.
Measured: Week 2 ; Week 4
Participant-rated acceptability of the test environment - Sound
Acceptability and appreciation of the sound of the environment assessed using Likert scales and free-text fields. Comparison by condition and metabolic status. Scale range should be entered exactly as used in source questionnaires.
Measured: Week 2 ; Week 4
Participant-rated acceptability of the test environment - Odor
Acceptability and appreciation of the odor of the environment assessed using Likert scales and free-text fields. Comparison by condition and metabolic status. Scale range should be entered exactly as used in source questionnaires.
Measured: Week 2 ; Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two-period, two-sequence crossover study (AB/BA) comparing food odor stimulation versus control condition during an OGTT. Randomization is stratified by sex and metabolic group, with restricted permuted blocks of variable size. The washout period between study periods is 4 weeks (±3 days).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638111
- Sponsor's protocol ID
- 69HCL25_1107
- Acronym
- SENSILNS
- Status last verified
- Jun 2026
- First submitted
- 19 Mar 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No IPD sharing statement is provided in the available protocol for the moment.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cephalic Phase Insulin Release Induced by an Environmental Food Odor Stimulus on Glucose Homeostasis According to Insulin Sensitivity Level
- ClinicalTrials.gov ID
- NCT07638111
- Acronym / sponsor ID
- SENSILNS / 69HCL25_1107
- Conditions
- Obesity & Overweight, Insulin Resistance Syndrome
- Keywords
- Glucose Homeostasis, Cephalic Phase Insulin Release, Food odor, Olfaction, Oral glucose tolerance test, Insulin secretion, GLP-1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recent experimental and translational data suggest that olfactory cues may contribute to metabolic regulation through anticipatory cephalic phase responses. Cephalic phase insulin release (CPIR) is an early preabsorptive insulin response triggered by sensory food-related stimuli before nutrient absorption. Preclinical data generated by the study team suggest that food-odor-induced CPIR involves an olfactory bulb-pancreas axis and may be altered in obesity. The present study is designed to investigate, in humans, whether a pleasant appetitive food odor delivered before glucose ingestion can induce measurable CPIR and improve post-load glucose handling.
The study uses a randomized AB/BA crossover design with two experimental visits after screening and inclusion. During one visit, participants are exposed to prerecorded food odor diffusion using a ScentRealm collar starting at T-10 minutes before ingestion of a 75 g glucose solution at T0. During the control visit, the same testing environment is maintained without odor stimulation. Serial blood sampling is performed before and after glucose ingestion to characterize glucose, insulin, C-peptide, and GLP-1 kinetics. The washout period is 4 weeks (±3 days), partly to align visits within the same menstrual cycle phase in women when applicable. The trial includes 20 adults aged 18 to 50 years: 10 without overweight and insulin-sensitive, and 10 with obesity and low-to-moderate insulin resistance defined using HOMA-IR.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two-period, two-sequence crossover study (AB/BA) comparing food odor stimulation versus control condition during an OGTT. Randomization is stratified by sex and metabolic group, with restricted permuted blocks of variable size. The washout period between study periods is 4 weeks (±3 days).
| Arm | Type | Receives |
|---|---|---|
| Food Odor Stimulation | Active comparator | Behavioral: Pleasant Food Odor Stimulation, Behavioral: Control Environmental ConditionParticipants are exposed to a pleasant appetitive food odor delivered through a ScentRealm collar beginning 10 minutes before ingestion of a 75 g oral glucose load and continuing according to a prerecorded sequence during the metabolic test visit. |
| Control Condition | Placebo comparator | Behavioral: Pleasant Food Odor Stimulation, Behavioral: Control Environmental ConditionParticipants undergo the same standardized metabolic test visit and OGTT procedures in the same test environment without food odor stimulation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (24 listed)
- 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 another drug
- Ongoing exclusion period from another study listed in the national volunteer file
- Legal protection measure (guardianship/curatorship)
- Deprivation of liberty by judicial or administrative decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleasant Food Odor StimulationExposure to an experimentally selected appetitive food odor (madeleine odor) delivered using a programmable ScentRealm collar in a standardized test room beginning at T-10 minutes before OGTT. | Behavioural | Control Condition, Food Odor Stimulation |
| Control Environmental ConditionStandardized testing environment identical to the experimental visit but without diffusion of the appetitive food odor. | Behavioural | Control Condition, Food Odor Stimulation |
Primary outcome
Within-subject difference in glucose incremental area under the curve (iAUC) from 0 to 120 minutes during OGTT
Time frame: During each experimental visit, from 0 to 120 minutes after ingestion of the 75 g oral glucose load
Primary endpoint is the mean within-subject difference between food odor and control conditions in glucose incremental area under the curve from 0 to 120 minutes after oral glucose ingestion. Glucose iAUC will be calculated using the trapezoidal method, baseline-adjusted to glucose at T0. The main analysis will also assess the interaction between condition (odor vs control) and metabolic status (no overweight/insulin-sensitive vs obesity with low-to-moderate insulin resistance). Unit should be specified in the statistical analysis plan according to assay reporting (for example mmol/L×min or mg/dL×min).
37 secondary outcomes
Preabsorptive and early post-ingestion insulin iAUC as a measure of cephalic phase insulin release
Time frame: From pre-OGTT odor exposure through 15 minutes after glucose ingestion during each experimental visit
Preabsorptive and early post-ingestion C-peptide iAUC
Time frame: From pre-OGTT odor exposure through 15 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - Δmax
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - Time to peak
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - Growth curve slope
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - Decay curve slope
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - ultradian oscillation indices
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - iAUC (0 to 120 min)
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - early glucose iAUC (0-30min)
Time frame: From 0 to 30 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - late glucose iAUC (30-120 min)
Time frame: From 30 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - iAUC (0-120 min)
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - iAUC (0-30min)
Time frame: From 0 to 30 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - iAUC (30-120min)
Time frame: From 30 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - Δmax
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - Time to peak
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - Growth curve slope
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - Decay curve slope
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - iAUC (0-120min)
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - iAUC (0-30min)
Time frame: From 0 to 30 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - iAUC (30-120min)
Time frame: From 30 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - Δmax
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - Time to peak
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - Growth curve slope
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - Decay curve slope
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - iAUC (0-120min)
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - iAUC (0-30min)
Time frame: From 0 to 30 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - iAUC (30-120min)
Time frame: From 30 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - Δmax
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - Time to peak
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - Growth curve slope
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - Decay curve slope
Time frame: From 0 to 120 minutes after glucose ingestion during each experimental visit
Correlation between CPIR characteristics and metabolic/hormonal responses
Time frame: Assessed using measurements collected during each experimental visit up to 120 minutes after glucose ingestion
Participant-rated appreciation of the experimental odor
Time frame: Week 2 ; Week 4
Participant-rated acceptability of the test environment - Temperature
Time frame: Week 2 ; Week 4
Participant-rated acceptability of the test environment - Lighting
Time frame: Week 2 ; Week 4
Participant-rated acceptability of the test environment - Sound
Time frame: Week 2 ; Week 4
Participant-rated acceptability of the test environment - Odor
Time frame: Week 2 ; Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Undecided. No IPD sharing statement is provided in the available protocol for the moment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleasant Food Odor Stimulation in people with Obesity & Overweight and Insulin Resistance Syndrome, run by Hospices Civils de Lyon at 1 site in France.
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 15 inclusion and 24 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: opening soon, as of the sponsor's last update on 10 Jun 2026. 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 France. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Laure MD CASTELL, Dr (+33 4 78 86 19 72 ext. +33, anne-laure.castell@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-subject difference in glucose incremental area under the curve (iAUC) from 0 to 120 minutes during OGTT (time frame: During each experimental visit, from 0 to 120 minutes after ingestion of the 75 g oral glucose load). 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 10 Jun 2026.