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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Food Odor StimulationActive comparator 2 interventions
Group B: Control ConditionPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
During each experimental visit, from 0 to 120 minutes after ingestion of the 75 g oral glucose load

Secondary outcomes

1

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).

Time frame
From pre-OGTT odor exposure through 15 minutes after glucose ingestion during each experimental visit
2

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.

Time frame
From pre-OGTT odor exposure through 15 minutes after glucose ingestion during each experimental visit
3

Glycemic kinetic response during OGTT - Δmax

Effect of condition and metabolic status on glycemic maximum change from baseline (Δmax)

Time frame
From 0 to 120 minutes after glucose ingestion during each experimental visit
4

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

Time frame
From 0 to 120 minutes after glucose ingestion during each experimental visit

Other outcomes

Sponsors and contacts

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