Clinical trial

SENSILINS: Impact of Cephalic Phase Insulin Release Induced by an Environmental Food Odor Stimulus on Glucose Homeostasis According to Insulin Sensitivity Level

Opening soon · Not applicable · 1 countries · Registry ID NCT07638111

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 50 Years
SexAll
Healthy volunteersAccepted
ConditionObesity & Overweight, Insulin Resistance Syndrome

Full registry criteria

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 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 * 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

Treatments and study arms

Pleasant Food Odor Stimulation

Behavioral

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 Condition

Behavioral

Standardized testing environment identical to the experimental visit but without diffusion of the appetitive food odor.

Primary outcomes

Within-subject difference in glucose incremental area under the curve (iAUC) from 0 to 120 minutes during OGTTDuring 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).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Centre de Recherche en Nutrition Humaine Rhône-Alpes, Centre Hospitalier Lyon Sud🇫🇷 Pierre-Bénite, France
Anne Laure CASTELL, MDContact
Nathalie Feugier-Favier, MDContact