SENSILINS: Impact of Cephalic Phase Insulin Release Induced by an Environmental Food Odor Stimulus on Glucose Homeostasis According to Insulin Sensitivity Level (SENSILNS)
2026年6月4日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Anne Laure MD CASTELL, Dr
- 電話番号：+33 +33 4 78 86 19 72
- メール：anne-laure.castell@chu-lyon.fr
研究場所
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Pierre-Bénite、フランス、69495
- Centre de Recherche en Nutrition Humaine Rhône-Alpes, Centre Hospitalier Lyon Sud
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コンタクト：
- Anne Laure CASTELL, MD
- 電話番号：+33 +33 4 78 86 19 72
- メール：anne-laure.castell@chu-lyon.fr
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コンタクト：
- Nathalie Feugier-Favier, MD
- 電話番号：+33 +33 4 78 86 29 54
- メール：nathalie.feugier@chu-lyon.fr
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
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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.
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プラセボコンパレーター：Control Condition
Participants undergo the same standardized metabolic test visit and OGTT procedures in the same test environment without food odor stimulation.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Within-subject difference in glucose incremental area under the curve (iAUC) from 0 to 120 minutes during OGTT
時間枠：During each experimental visit, from 0 to 120 minutes after ingestion of the 75 g oral glucose load
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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).
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During each experimental visit, from 0 to 120 minutes after ingestion of the 75 g oral glucose load
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Preabsorptive and early post-ingestion insulin iAUC as a measure of cephalic phase insulin release
時間枠：From pre-OGTT odor exposure through 15 minutes after glucose ingestion during each experimental visit
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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).
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From pre-OGTT odor exposure through 15 minutes after glucose ingestion during each experimental visit
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Preabsorptive and early post-ingestion C-peptide iAUC
時間枠：From pre-OGTT odor exposure through 15 minutes after glucose ingestion during each experimental visit
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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.
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From pre-OGTT odor exposure through 15 minutes after glucose ingestion during each experimental visit
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Glycemic kinetic response during OGTT - Δmax
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
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Effect of condition and metabolic status on glycemic maximum change from baseline (Δmax)
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From 0 to 120 minutes after glucose ingestion during each experimental visit
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Glycemic kinetic response during OGTT - Time to peak
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
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Effect of condition and metabolic status on the necessary amount of time to reach glycemic peak in minutes
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From 0 to 120 minutes after glucose ingestion during each experimental visit
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Glycemic kinetic response during OGTT - Growth curve slope
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
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Effect of condition and metabolic status on the slope of the glycemic growth curve from baseline
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From 0 to 120 minutes after glucose ingestion during each experimental visit
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Glycemic kinetic response during OGTT - Decay curve slope
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
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Effect of condition and metabolic status on the slope of the glycemic decay curve from the maximum (peak)
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From 0 to 120 minutes after glucose ingestion during each experimental visit
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Glycemic kinetic response during OGTT - ultradian oscillation indices
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
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Effect of condition and metabolic status on ultradian oscillation indices
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From 0 to 120 minutes after glucose ingestion during each experimental visit
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Glycemic kinetic response during OGTT - iAUC (0 to 120 min)
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
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Effect of condition and metabolic status on Incremental Area Under the Curve (IAUC) from 0 to 120 min for glucose
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From 0 to 120 minutes after glucose ingestion during each experimental visit
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Glycemic kinetic response during OGTT - early glucose iAUC (0-30min)
時間枠：From 0 to 30 minutes after glucose ingestion during each experimental visit
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Effect of condition and metabolic status on glucose Incremental Area Under the Curve (IAUC) from 0 to 30 min
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From 0 to 30 minutes after glucose ingestion during each experimental visit
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Glycemic kinetic response during OGTT - late glucose iAUC (30-120 min)
時間枠：From 30 to 120 minutes after glucose ingestion during each experimental visit
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Effect of condition and metabolic status on glucose Incremental Area Under the Curve (IAUC) from 30 to 120 min
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From 30 to 120 minutes after glucose ingestion during each experimental visit
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Hormonal response parameters for insulin during OGTT - iAUC (0-120 min)
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
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Total Incremental Area Under the Curve (iAUC) from 0 to 120 minutes
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From 0 to 120 minutes after glucose ingestion during each experimental visit
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Hormonal response parameters for insulin during OGTT - iAUC (0-30min)
時間枠：From 0 to 30 minutes after glucose ingestion during each experimental visit
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Insulin Incremental Area Under the Curve (IAUC) from 0 to 30 min
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From 0 to 30 minutes after glucose ingestion during each experimental visit
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Hormonal response parameters for insulin during OGTT - iAUC (30-120min)
時間枠：From 30 to 120 minutes after glucose ingestion during each experimental visit
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Insulin Incremental Area Under the Curve (IAUC) from 30 to 120 min
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From 30 to 120 minutes after glucose ingestion during each experimental visit
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Hormonal response parameters for insulin during OGTT - Δmax
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
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The value of the maximum (peak) of the curve relative to the baseline value for insulin
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From 0 to 120 minutes after glucose ingestion during each experimental visit
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Hormonal response parameters for insulin during OGTT - Time to peak
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
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Necessary amount of time for insulin to reach peak in minutes
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From 0 to 120 minutes after glucose ingestion during each experimental visit
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Hormonal response parameters for insulin during OGTT - Growth curve slope
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
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Slope of the insulin growth curve from baseline
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From 0 to 120 minutes after glucose ingestion during each experimental visit
|
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Hormonal response parameters for insulin during OGTT - Decay curve slope
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
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Slope of the insulin decay curve from the maximum (peak)
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From 0 to 120 minutes after glucose ingestion during each experimental visit
|
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Hormonal response parameters for C-peptide during OGTT - iAUC (0-120min)
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
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C-peptide Incremental Area Under the Curve (IAUC) from 0 to 120 min
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From 0 to 120 minutes after glucose ingestion during each experimental visit
|
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Hormonal response parameters for C-peptide during OGTT - iAUC (0-30min)
時間枠：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
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From 0 to 30 minutes after glucose ingestion during each experimental visit
|
|
Hormonal response parameters for C-peptide during OGTT - iAUC (30-120min)
時間枠：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
時間枠：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
時間枠：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
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
|
Slope of the C-peptide growth curve from baseline
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From 0 to 120 minutes after glucose ingestion during each experimental visit
|
|
Hormonal response parameters for C-peptide during OGTT - Decay curve slope
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
|
Slope of the C-peptide decay curve from the maximum (peak)
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From 0 to 120 minutes after glucose ingestion during each experimental visit
|
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Hormonal response parameters for GLP-1 during OGTT - iAUC (0-120min)
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
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GLP1 Incremental Area Under the Curve (IAUC) from 0 to 120 min
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From 0 to 120 minutes after glucose ingestion during each experimental visit
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Hormonal response parameters for GLP-1 during OGTT - iAUC (0-30min)
時間枠：From 0 to 30 minutes after glucose ingestion during each experimental visit
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GLP-1 Incremental Area Under the Curve (IAUC) from 0 to 30 min
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From 0 to 30 minutes after glucose ingestion during each experimental visit
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Hormonal response parameters for GLP-1 during OGTT - iAUC (30-120min)
時間枠：From 30 to 120 minutes after glucose ingestion during each experimental visit
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GLP-1 Incremental Area Under the Curve (IAUC) from 30 to 120 min
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From 30 to 120 minutes after glucose ingestion during each experimental visit
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Hormonal response parameters for GLP-1 during OGTT - Δmax
時間枠：From 0 to 120 minutes after glucose ingestion during each experimental visit
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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
時間枠：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
時間枠：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
時間枠：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
|
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Correlation between CPIR characteristics and metabolic/hormonal responses
時間枠：Assessed using measurements collected during each experimental visit up to 120 minutes after glucose ingestion
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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.
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Assessed using measurements collected during each experimental visit up to 120 minutes after glucose ingestion
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Participant-rated appreciation of the experimental odor
時間枠：Week 2 ; Week 4
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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.
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Week 2 ; Week 4
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Participant-rated acceptability of the test environment - Temperature
時間枠：Week 2 ; Week 4
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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.
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Week 2 ; Week 4
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Participant-rated acceptability of the test environment - Lighting
時間枠：Week 2 ; Week 4
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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.
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Week 2 ; Week 4
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Participant-rated acceptability of the test environment - Sound
時間枠：Week 2 ; Week 4
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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.
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Week 2 ; Week 4
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Participant-rated acceptability of the test environment - Odor
時間枠：Week 2 ; Week 4
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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.
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Week 2 ; Week 4
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2027年7月1日
研究の完了 (推定)
2027年7月1日
試験登録日
最初に提出
2026年3月19日
QC基準を満たした最初の提出物
2026年6月4日
最初の投稿 (実際)
2026年6月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月10日
QC基準を満たした最後の更新が送信されました
2026年6月4日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 69HCL25_1107
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
No IPD sharing statement is provided in the available protocol for the moment.
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米国FDA規制医薬品の研究
いいえ
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いいえ
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