- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07638111
SENSILINS: Impact of Cephalic Phase Insulin Release Induced by an Environmental Food Odor Stimulus on Glucose Homeostasis According to Insulin Sensitivity Level (SENSILNS)
Impact of Cephalic Phase Insulin Release Induced by an Environmental Food Odor Stimulus on Glucose Homeostasis According to Insulin Sensitivity Level
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Anne Laure MD CASTELL, Dr
- Número de telefone: +33 +33 4 78 86 19 72
- E-mail: anne-laure.castell@chu-lyon.fr
Locais de estudo
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Pierre-Bénite, França, 69495
- Centre de Recherche en Nutrition Humaine Rhône-Alpes, Centre Hospitalier Lyon Sud
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Contato:
- Anne Laure CASTELL, MD
- Número de telefone: +33 +33 4 78 86 19 72
- E-mail: anne-laure.castell@chu-lyon.fr
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Contato:
- Nathalie Feugier-Favier, MD
- Número de telefone: +33 +33 4 78 86 29 54
- E-mail: nathalie.feugier@chu-lyon.fr
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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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Comparador de Placebo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Within-subject difference in glucose incremental area under the curve (iAUC) from 0 to 120 minutes during OGTT
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Preabsorptive and early post-ingestion insulin iAUC as a measure of cephalic phase insulin release
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: From 0 to 30 minutes after glucose ingestion during each experimental visit
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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
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Hormonal response parameters for C-peptide during OGTT - iAUC (30-120min)
Prazo: From 30 to 120 minutes after glucose ingestion during each experimental visit
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C-peptide 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 C-peptide during OGTT - Δmax
Prazo: 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 C-peptide
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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 - Time to peak
Prazo: From 0 to 120 minutes after glucose ingestion during each experimental visit
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Necessary amount of time for C-peptide 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 C-peptide during OGTT - Growth curve slope
Prazo: From 0 to 120 minutes after glucose ingestion during each experimental visit
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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
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Hormonal response parameters for C-peptide during OGTT - Decay curve slope
Prazo: From 0 to 120 minutes after glucose ingestion during each experimental visit
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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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
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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 - Time to peak
Prazo: From 0 to 120 minutes after glucose ingestion during each experimental visit
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Necessary amount of time for GLP-1 to reach peak in minutes
|
From 0 to 120 minutes after glucose ingestion during each experimental visit
|
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Hormonal response parameters for GLP-1 during OGTT - Growth curve slope
Prazo: From 0 to 120 minutes after glucose ingestion during each experimental visit
|
Slope of the GLP-1 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 GLP-1 during OGTT - Decay curve slope
Prazo: From 0 to 120 minutes after glucose ingestion during each experimental visit
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Slope of the GLP-1 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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Correlation between CPIR characteristics and metabolic/hormonal responses
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Distúrbios Nutricionais
- Doenças Metabólicas
- Supernutrição
- Peso corporal
- Distúrbios do Metabolismo da Glicose
- Distúrbios da Sensação
- Resistência a insulina
- Hiperinsulinismo
- Distúrbios do olfato
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Anosmia
- Excesso de peso
- Obesidade
- Síndrome metabólica
Outros números de identificação do estudo
- 69HCL25_1107
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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