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

4 czerwca 2026 zaktualizowane przez: Hospices Civils de Lyon

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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

20

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

      • Pierre-Bénite, Francja, 69495
        • Centre de Recherche en Nutrition Humaine Rhône-Alpes, Centre Hospitalier Lyon Sud
        • Kontakt:
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Food Odor Stimulation
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.
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.
Standardized testing environment identical to the experimental visit but without diffusion of the appetitive food odor.
Komparator placebo: Control Condition
Participants undergo the same standardized metabolic test visit and OGTT procedures in the same test environment without food odor stimulation.
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.
Standardized testing environment identical to the experimental visit but without diffusion of the appetitive food odor.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Within-subject difference in glucose incremental area under the curve (iAUC) from 0 to 120 minutes during OGTT
Ramy czasowe: 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).
During each experimental visit, from 0 to 120 minutes after ingestion of the 75 g oral glucose load

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Preabsorptive and early post-ingestion insulin iAUC as a measure of cephalic phase insulin release
Ramy czasowe: From pre-OGTT odor exposure through 15 minutes after glucose ingestion during each experimental visit
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).
From pre-OGTT odor exposure through 15 minutes after glucose ingestion during each experimental visit
Preabsorptive and early post-ingestion C-peptide iAUC
Ramy czasowe: From pre-OGTT odor exposure through 15 minutes after glucose ingestion during each experimental visit
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.
From pre-OGTT odor exposure through 15 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - Δmax
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Effect of condition and metabolic status on glycemic maximum change from baseline (Δmax)
From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - Time to peak
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Effect of condition and metabolic status on the necessary amount of time to reach glycemic peak in minutes
From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - Growth curve slope
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Effect of condition and metabolic status on the slope of the glycemic growth curve from baseline
From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - Decay curve slope
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Effect of condition and metabolic status on the slope of the glycemic decay curve from the maximum (peak)
From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - ultradian oscillation indices
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Effect of condition and metabolic status on ultradian oscillation indices
From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - iAUC (0 to 120 min)
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Effect of condition and metabolic status on Incremental Area Under the Curve (IAUC) from 0 to 120 min for glucose
From 0 to 120 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - early glucose iAUC (0-30min)
Ramy czasowe: From 0 to 30 minutes after glucose ingestion during each experimental visit
Effect of condition and metabolic status on glucose Incremental Area Under the Curve (IAUC) from 0 to 30 min
From 0 to 30 minutes after glucose ingestion during each experimental visit
Glycemic kinetic response during OGTT - late glucose iAUC (30-120 min)
Ramy czasowe: From 30 to 120 minutes after glucose ingestion during each experimental visit
Effect of condition and metabolic status on glucose Incremental Area Under the Curve (IAUC) from 30 to 120 min
From 30 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - iAUC (0-120 min)
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Total Incremental Area Under the Curve (iAUC) from 0 to 120 minutes
From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - iAUC (0-30min)
Ramy czasowe: From 0 to 30 minutes after glucose ingestion during each experimental visit
Insulin Incremental Area Under the Curve (IAUC) from 0 to 30 min
From 0 to 30 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - iAUC (30-120min)
Ramy czasowe: From 30 to 120 minutes after glucose ingestion during each experimental visit
Insulin Incremental Area Under the Curve (IAUC) from 30 to 120 min
From 30 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - Δmax
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
The value of the maximum (peak) of the curve relative to the baseline value for insulin
From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - Time to peak
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Necessary amount of time for insulin to reach peak in minutes
From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - Growth curve slope
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Slope of the insulin growth curve from baseline
From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for insulin during OGTT - Decay curve slope
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Slope of the insulin decay curve from the maximum (peak)
From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - iAUC (0-120min)
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
C-peptide Incremental Area Under the Curve (IAUC) from 0 to 120 min
From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - iAUC (0-30min)
Ramy czasowe: From 0 to 30 minutes after glucose ingestion during each experimental visit
C-peptide Incremental Area Under the Curve (IAUC) from 0 to 30 min
From 0 to 30 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - iAUC (30-120min)
Ramy czasowe: From 30 to 120 minutes after glucose ingestion during each experimental visit
C-peptide Incremental Area Under the Curve (IAUC) from 30 to 120 min
From 30 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - Δmax
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
The value of the maximum (peak) of the curve relative to the baseline value for C-peptide
From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - Time to peak
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Necessary amount of time for C-peptide to reach peak in minutes
From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - Growth curve slope
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Slope of the C-peptide growth curve from baseline
From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for C-peptide during OGTT - Decay curve slope
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Slope of the C-peptide decay curve from the maximum (peak)
From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - iAUC (0-120min)
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
GLP1 Incremental Area Under the Curve (IAUC) from 0 to 120 min
From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - iAUC (0-30min)
Ramy czasowe: From 0 to 30 minutes after glucose ingestion during each experimental visit
GLP-1 Incremental Area Under the Curve (IAUC) from 0 to 30 min
From 0 to 30 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - iAUC (30-120min)
Ramy czasowe: From 30 to 120 minutes after glucose ingestion during each experimental visit
GLP-1 Incremental Area Under the Curve (IAUC) from 30 to 120 min
From 30 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - Δmax
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
The value of the maximum (peak) of the curve relative to the baseline value for GLP-1
From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - Time to peak
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Necessary amount of time for GLP-1 to reach peak in minutes
From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - Growth curve slope
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Slope of the GLP-1 growth curve from baseline
From 0 to 120 minutes after glucose ingestion during each experimental visit
Hormonal response parameters for GLP-1 during OGTT - Decay curve slope
Ramy czasowe: From 0 to 120 minutes after glucose ingestion during each experimental visit
Slope of the GLP-1 decay curve from the maximum (peak)
From 0 to 120 minutes after glucose ingestion during each experimental visit
Correlation between CPIR characteristics and metabolic/hormonal responses
Ramy czasowe: Assessed using measurements collected during each experimental visit up to 120 minutes after glucose ingestion
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.
Assessed using measurements collected during each experimental visit up to 120 minutes after glucose ingestion
Participant-rated appreciation of the experimental odor
Ramy czasowe: Week 2 ; Week 4
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.
Week 2 ; Week 4
Participant-rated acceptability of the test environment - Temperature
Ramy czasowe: Week 2 ; Week 4
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.
Week 2 ; Week 4
Participant-rated acceptability of the test environment - Lighting
Ramy czasowe: Week 2 ; Week 4
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.
Week 2 ; Week 4
Participant-rated acceptability of the test environment - Sound
Ramy czasowe: Week 2 ; Week 4
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.
Week 2 ; Week 4
Participant-rated acceptability of the test environment - Odor
Ramy czasowe: Week 2 ; Week 4
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.
Week 2 ; Week 4

Współpracownicy i badacze

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Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 lipca 2027

Ukończenie studiów (Szacowany)

1 lipca 2027

Daty rejestracji na studia

Pierwszy przesłany

19 marca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

10 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

No IPD sharing statement is provided in the available protocol for the moment.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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