- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07636369
The SAVOR Study: Appetite and Physiological Responses (SAVOR)
3 juin 2026 mis à jour par: Darel Toh, Singapore Institute of Food and Biotechnology Innovation
Seniors' Appetite: Vibrant Opportunities for Revitalization (SAVOR)
The study aims to identify key physiological factors that differentiate older adults with healthy appetites from those experiencing appetite decline.
The investigators hypothesize that seniors experiencing appetite decline will exhibit distinct oro-sensory, gastrointestinal, and hormonal profiles compared to seniors with healthy appetites, suggesting underlying biological mechanisms contributing to reduced appetite.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
Appetite decline in older adults, or anorexia of aging, is a prevalent geriatric syndrome associated with decreased quality of life, increased risk of malnutrition, and accelerated decline in health.
While current nutritional guidelines often emphasize increasing nutrient density, these strategies often fail to address the root causes of diminished appetite.
Emerging research highlights the critical role of age-related physiological changes, particularly dysregulation of the gut-brain axis, altered sensory perception, and hormonal imbalances, in suppressing appetite.
Notably, existing evidence is largely derived from Western populations, which may not fully reflect the influence of cultural and lifestyle factors on appetite in Asian seniors.
This leaves a significant gap in understanding and addressing appetite loss within this specific demographic.
This study aims to address this gap by comprehensively investigating the physiological mechanisms underlying appetite regulation in Asian seniors, to identify key determinants that differentiate individuals with healthy appetites from those experiencing a decline.
By assessing the relationships between oro-sensory function, gastric dynamics, neuro-hormonal regulation, gut microbiome composition and subjective appetite, this study seeks to provide a deeper understanding of the biological pathways driving appetite differences in this population.
The findings of this study will lay the groundwork for future research aimed at developing culturally sensitive and effective interventions that can restore appetite, improve nutritional status, and ultimately enhance the health span and quality of life for older adults in Singapore and beyond.
Furthermore, this work has the potential to drive innovation in the food and nutrition industry, leading to the development of tailored products and dietary strategies that effectively address the unique nutritional needs of aging populations, ultimately impacting public health recommendations and policies related to senior nutrition.
Type d'étude
Interventionnel
Inscription (Estimé)
20
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Rina Quek, MSc
- Numéro de téléphone: 64074379
- E-mail: rina_quek@a-star.edu.sg
Sauvegarde des contacts de l'étude
- Nom: Ashley Yu, BSc
- E-mail: ashley_yu@a-star.edu.sg
Lieux d'étude
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Singapore, Singapour
- Clinical Nutrition Research Centre
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Contact:
- Darel Toh, PhD
- Numéro de téléphone: 64074149
- E-mail: darel_toh@a-star.edu.sg
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Contact:
- Rina Quek, MSc
- E-mail: rina_quek@a-star.edu.sg
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Postmenopausal female
- Aged 65-74 years
- Habitual breakfast consumer (consumes breakfast between 7am to 10am)
- Willingness to consume meals and follow intervention protocol
- English speaking
Exclusion Criteria:
- BMI ≥ 27.5
- Diagnosed with medical condition that may influence appetite or microbiome (e.g. diabetes, thyroid disorders, gastrointestinal diseases)
- Currently taking any medications or supplements that may influence appetite or the microbiome (e.g. probiotics, antibiotics, appetite stimulants/suppressants) one month prior to their first visit in consultation with study physician, PI and study team
- Following a special diet for weight management (e.g. low-calorie, low carbohydrate)
- History of bariatrics surgery
- Intentional attempt to change body weight or composition
- History of severe vasovagal syncope (blackouts or near faints) following blood draw
- Drug abuse within last 5 years
- Excessive alcoholic beverage consumption > 2 servings per day (1 serving defined as 360 mL beer, 150 mL wine or 45 mL distilled spirits)
- Smoking (cigarette, e-cigarette, cigar, pipe, vape)
- Engaging in habitual vigorous physical activity (as defined by physical activity questionnaire-PAQ)
- Loose teeth or jaw pain
- Not missing > 2 non-wisdom molars
- Involvement in other clinical studies that may influence the outcome of the study
- A study team member or their immediate family member
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Chicken porridge
Rice congee with shredded chicken and vegetable oil
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This is a mixed meal tolerance test intended to elicit gut hormone responses reflective of real-world dietary patterns.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Ad Libitum Lunch
Délai: Participants will be given 30 minutes to consume the meal until they are comfortably full, 180 minutes after the start of the intervention.
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Participants will be asked to eat as much of the stir-fried beehoon as they want until they are comfortably full, to measure the exact calorie intake by weighing the food before and after eating.
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Participants will be given 30 minutes to consume the meal until they are comfortably full, 180 minutes after the start of the intervention.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Palatability questionnaire
Délai: Administered after consuming test meal and after consuming the ad libitum meal.
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Palatability appetite questionnaire, rated on a visual analogue scale is a psychometric assessment tool where participants rate their subjective sensory experience-such as taste, smell, or pleasantness-by marking a point along a continuous 100 mm line anchored by opposing extremes (e.g., "extremely unpleasant" to "extremely pleasant").
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Administered after consuming test meal and after consuming the ad libitum meal.
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Appetite hormones
Délai: Blood samples will be collected at timepoints (t = -15 minute (baseline), 30, 60, 90, 120 and 180 minutes)
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GLP-1, PYY and Acyl-ghrelin will be used to measure hormones related to appetite.
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Blood samples will be collected at timepoints (t = -15 minute (baseline), 30, 60, 90, 120 and 180 minutes)
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Subjective Appetite Questionnaire
Délai: Measurement is taken at t = -15 minute (baseline), 10, 30, 60, 90, 120 and 180 minutes
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A subjective appetite questionnaire utilizes a Visual Analogue Scale to quantify a person's current metabolic state by measuring four key sensations: hunger, fullness, desire to eat, and prospective food consumption.
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Measurement is taken at t = -15 minute (baseline), 10, 30, 60, 90, 120 and 180 minutes
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Gastric Ultrasound
Délai: Measurements will be taken at t = -15 minute (baseline), 15, 45, 105 and 165 minutes
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Gastric ultrasound will measure the gastric emptying rate postprandially.
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Measurements will be taken at t = -15 minute (baseline), 15, 45, 105 and 165 minutes
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Stool collected using the OMNIgene and OMNImet
Délai: Baseline stool sample will be collected once between screening and intervention day.
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Stool sample will be collected in the OMNIgene-GUT and OMNImet-GUT tube for measurements that may include microbiome profiling, untargeted and targeted metabolome (e.g.
bile acids and short-chain fatty acids profiling).
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Baseline stool sample will be collected once between screening and intervention day.
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Olfactory Acuity (SCENTinel)
Délai: Baseline measurement administered once during screening, takes approximately 5-10 minutes
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Olfactory acuity will be assessed using a simple, non-invasive SCENTinel rapid smell test.
Participants will be presented with test cards containing various odors, and will be asked to detect, rate, and identify the odors.
The test assesses the participant's ability to perceive and recognize smells, providing information on their overall sense of smell.
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Baseline measurement administered once during screening, takes approximately 5-10 minutes
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Taste Acuity Test (WETT)
Délai: Baseline measurement administered once during screening, takes approximately 10-15 minutes
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The Waterless Empirical Taste Test (WETT) is a sensory method for assessing how well participants can recognise and detect basic tastes.
Participants will taste pre-moistened, paper-based test strips for the five basic tastes: sweet, sour, salty, bitter, and umami.
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Baseline measurement administered once during screening, takes approximately 10-15 minutes
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Blood plasma (Cytokines)
Délai: t = -15 minute (baseline), 30, 60, 90, 120, 180 minutes
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Blood samples may also be analyzed for indicators of inflammation including cytokines testing
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t = -15 minute (baseline), 30, 60, 90, 120, 180 minutes
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Blood plasma (Bile acids and short-chain fatty acids profiling)
Délai: t= -15 minute (baseline), 30, 60, 90, 120, 180 minutes
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Blood samples collected may be used to analyse biomarkers related to nutrition and digestive health e.g.
bile acid and short-chain fatty acids profiling
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t= -15 minute (baseline), 30, 60, 90, 120, 180 minutes
|
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Bite Strength
Délai: Baseline measurement that may be administered once during screening or test session, as schedule and equipment permits. Takes only a few minutes.
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Bite strength will be measured using a bite force device (non-invasive) that records the maximum force a participant can exert while biting.
Multiple measurements will be taken with rest periods in between to prevent fatigue.
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Baseline measurement that may be administered once during screening or test session, as schedule and equipment permits. Takes only a few minutes.
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Tongue Strength (Tongue Pressure)
Délai: Baseline measurement that may be administered once during screening or test session, as schedule and equipment permits. Takes approximately 5 minutes.
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Tongue pressure will be measured using a device equipped with a disposable air-filled bulb placed between the tongue and the hard palate.
Participants will be instructed to press the bulb with their tongue as firmly as possible for a few seconds.
Multiple measurements will be taken with rest periods in between to ensure accuracy and prevent fatigue.
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Baseline measurement that may be administered once during screening or test session, as schedule and equipment permits. Takes approximately 5 minutes.
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Health and Lifestyle questionnaire
Délai: Baseline measurement that is completed during screening visit
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This questionnaire is to evaluate the participant's eligibility for the study.
It consist of participant information, medical and health history, lifestyle and diet, physical activity.
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Baseline measurement that is completed during screening visit
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3-day food record
Délai: Administered between screening and actual test session, to be completed on 2 weekdays and 1 weekend.
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A 3-day food record is a detailed diary where participants document everything they eat and drink over two weekdays and one weekend day to provide an accurate snapshot of their typical nutritional intake.
This is done using household measures (or digital scales), where exact portion sizes, cooking methods and brand names of all items are used.
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Administered between screening and actual test session, to be completed on 2 weekdays and 1 weekend.
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Gastrointestinal Symptom Rating Scale (GSRS)
Délai: Baseline measurement administered once during screening.
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The Gastrointestinal Symptom Rating Scale (GSRS) is a validated 15-item questionnaire used to assess the presence and severity of common digestive issues across five key areas: abdominal pain, reflux, diarrhea, constipation, and indigestion.
Participants rate each symptom on a 7-point Likert scale-ranging from "no discomfort" to "very severe discomfort"-to provide a quantifiable measurement of their gastrointestinal well-being.
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Baseline measurement administered once during screening.
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Council on Nutrition Appetite Questionnaire (CNAQ)
Délai: Baseline measurement administered once during screening, takes approximately 5-10 minutes
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The Council on Nutrition Appetite Questionnaire (CNAQ) is a brief, 8-item screening tool designed to predict future weight loss by assessing a participant's appetite and dietary habits.
It asks about sensations like hunger, how quickly a participant feel full, and how food tastes to determine if a participant is at risk for nutritional deficiencies or significant weight changes over the coming months.
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Baseline measurement administered once during screening, takes approximately 5-10 minutes
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Pittsburgh Sleep Quality Index (PSQI)
Délai: Baseline measurement administered once during screening, takes approximately 5-10 minutes
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The Pittsburgh Sleep Quality Index (PSQI) is a validated 19-item questionnaire used to measure sleep quality and disturbances over a one-month timeframe.
It evaluates seven key areas-including sleep duration, how long it takes to fall asleep, sleep disruptions, and daytime tiredness-to generate a single overall score that differentiates between "good" and "poor" sleepers in clinical research.
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Baseline measurement administered once during screening, takes approximately 5-10 minutes
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Geriatric Depression Scale (GDS)
Délai: Administered once during screening, takes approximately 5 minutes
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The Geriatric Depression Scale (GDS) is a 30-item questionnaire-often shortened to a 15-item version-specifically designed to screen for depression in older adults.
Unlike general depression scales, it uses a simple "yes" or "no" format and focuses primarily on psychological and mood-related symptoms rather than physical complaints (like aches or fatigue), which can often overlap with normal aging or other medical conditions.
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Administered once during screening, takes approximately 5 minutes
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Dutch Eating Behavior Questionnaire (DEBQ)
Délai: Baseline measurement administered once during screening, takes approximately 10 minutes
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The Dutch Eating Behavior Questionnaire (DEBQ) is a 33-item psychometric scale used to assess the distinct psychological factors and eating styles that can lead to overeating or weight gain.
It breaks eating behaviors down into three core subscales - emotional eating, external eating and restrained eating.
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Baseline measurement administered once during screening, takes approximately 10 minutes
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Leeds Food Preference Questionnaire (LFPQ)
Délai: Baseline measurement administered once during screening, takes approximately 10-15 minutes
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The Leeds Food Preference Questionnaire (LFPQ) is a computer-based tool used in behavioral research to measure different psychological components of food preference and appetite.
It uses a series of food images to evaluate two distinct aspects of food reward: explicit liking and implicit wanting.
The tool categorizes these preferences across different food characteristics, specifically comparing high-fat vs. low-fat foods, and sweet vs. savory tastes.
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Baseline measurement administered once during screening, takes approximately 10-15 minutes
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Three-Factor Eating Questionnaire (TFEQ)
Délai: Baseline measurement administered once during screening, takes approximately 10 minutes
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The Three-Factor Eating Questionnaire (TFEQ) is a validated psychometric tool used to measure three distinct dimensions of human eating behavior and cognitive dietary control.
It evaluates eating habits across three primary subscales: cognitive restraint, disinhibition and hunger
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Baseline measurement administered once during screening, takes approximately 10 minutes
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International Physical Activity Questionnaire (IPAQ)
Délai: Baseline measurement administered once during screening, takes approximately 10 minutes
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The International Physical Activity Questionnaire (IPAQ) is a validated tool that measures a person's physical activity levels over a 7-day period.
It records the total time spent across four distinct intensities: vigorous activity (like running or heavy lifting), moderate activity (like steady cycling), walking, and weekday sitting time.
These tracked minutes are converted into a standard metabolic score (MET-minutes/week), which is then used to classify an individual's overall physical activity level into one of three distinct categories: Low, Moderate, or High.
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Baseline measurement administered once during screening, takes approximately 10 minutes
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Darel Toh, PhD, Clinical Nutrition Research Centre
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Sturm K, MacIntosh CG, Parker BA, Wishart J, Horowitz M, Chapman IM. Appetite, food intake, and plasma concentrations of cholecystokinin, ghrelin, and other gastrointestinal hormones in undernourished older women and well-nourished young and older women. J Clin Endocrinol Metab. 2003 Aug;88(8):3747-55. doi: 10.1210/jc.2002-021656.
- Dagbasi A, Warner J, Catterall V, Smith K, Crabtree DR, Carroll B, Frost G, Holliday A. Augmented gut hormone response to feeding in older adults exhibiting low appetite. Appetite. 2024 Oct 1;201:107415. doi: 10.1016/j.appet.2024.107415. Epub 2024 May 16.
- Atalayer D, Astbury NM. Anorexia of aging and gut hormones. Aging Dis. 2013 Oct 1;4(5):264-75. doi: 10.14336/AD.2013.0400264.
- Dagenais S, Fielding RA, Clark S, Cantu C, Prasad S, Groarke JD. Anorexia in Medicare Fee-for-Service Beneficiaries: A Claims-Based Analysis of Epidemiology and Mortality. J Nutr Health Aging. 2023;27(3):184-191. doi: 10.1007/s12603-023-1882-4.
- Morley JE. Peptides and aging: Their role in anorexia and memory. Peptides. 2015 Oct;72:112-8. doi: 10.1016/j.peptides.2015.04.007. Epub 2015 Apr 17.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
1 août 2026
Achèvement de l'étude (Estimé)
1 octobre 2026
Dates d'inscription aux études
Première soumission
20 mai 2026
Première soumission répondant aux critères de contrôle qualité
3 juin 2026
Première publication (Réel)
9 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-133
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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