Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting

9 novembre 2026 mis à jour par: LOAM Science

A Randomized, Participant-Masked, Crossover Study Evaluating Postprandial Glycemic Response to Three Sweetener Preloads Consumed Before a Standardized Mixed Meal in Healthy Adults

This study is using a double-blind, randomize crossover evaluating the impact of three different sweeteners on postprandial glycemic response in a mixed meal setting. In 50 individuals, postprandial glucose response will be evaluated as a primary objective. Secondary objectives include additional measures of glucose response as well general gastrointestinal response to the sweeteners, assessed through a series of questionnaires.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

50

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

Lieux d'étude

    • California
      • San Francisco, California, États-Unis, 94109
        • Recrutement
        • Alethios
        • Contact:
          • Zeenia Framroze
          • Numéro de téléphone: 650-206-8006

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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Adults 18 or older
  • Body mass index between 18.5 and 29.9 kg/m2, inclusive, based on self-reported height and weight.
  • Self-reported general good health, without a diagnosis of diabetes or prediabetes.
  • Willing and able to consume the standardized study breakfast, consisting of a plain bagel with plain cream cheese, on six specified mornings.
  • Willing to wear a continuous glucose monitor continuously on the upper arm for approximately 10 consecutive days.
  • Willing to observe an overnight fast of at least 8 hours before each test morning and to follow test-day standardization instructions.
  • Owns a compatible smartphone with reliable internet access and is willing to install the required study and sensor applications.
  • Resides in the United States and is able to receive shipments at a residential address.
  • Able to read, understand, and communicate in English.
  • Willing and able to provide electronic informed consent through a digital platform.

Exclusion Criteria:

  • Diagnosis of type 1 diabetes, type 2 diabetes, prediabetes, or a history of gestational diabetes.
  • Current use of any glucose-lowering medication, including insulin, metformin, sulfonylureas, GLP-1 receptor agonists, DPP-4 inhibitors, or SGLT2 inhibitors.
  • Current or recent use, within 30 days of consent, of systemic corticosteroids or any other medication known to materially alter glucose metabolism.
  • Celiac disease, wheat or gluten allergy or intolerance, or any dairy allergy or lactose intolerance that would preclude consumption of the standardized study breakfast or exclusion of gluten or dairy from the diet for any other reason that would preclude consumption of the standardized breakfast.
  • Known allergy or sensitivity to steviol glycosides, sucrose, or any declared component of the study preloads.
  • Known adhesive allergy or history of significant skin reaction to wearable sensors or medical adhesives.
  • Diagnosed gastrointestinal condition affecting digestion or absorption, including inflammatory bowel disease, gastroparesis, or prior bariatric or major gastrointestinal surgery.
  • Current eating disorder, or a diagnosed eating disorder within the previous 12 months.
  • Pregnant, breastfeeding, or planning to become pregnant during the study period.
  • Regular night-shift work, or planned travel across more than two time zones during the study period.
  • Planned substantial change in diet, physical activity, or body weight during the study period.
  • Current alcohol use disorder or substance use disorder.
  • Participation in another interventional research study within 30 days of consent or concurrently with this study.
  • Any condition or circumstance that, in the judgment of the Principal Investigator, would compromise participant safety or the integrity of the study data.

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: Science basique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Sequence 1

Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order.

A fiber-based sweetener produced by LOAM.

Table sugar

Stevia

Expérimental: Sequence 2

Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order.

A fiber-based sweetener produced by LOAM.

Table sugar

Stevia

Expérimental: Sequence 3

Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order.

A fiber-based sweetener produced by LOAM.

Table sugar

Stevia

Expérimental: Sequence 4

Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order.

A fiber-based sweetener produced by LOAM.

Table sugar

Stevia

Expérimental: Sequence 5

Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order.

A fiber-based sweetener produced by LOAM.

Table sugar

Stevia

Expérimental: Sequence 6

Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order.

A fiber-based sweetener produced by LOAM.

Table sugar

Stevia

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Postprandial Area Under the Curve to 120 Minutes
Délai: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Area under the curve above baseline from time zero (the start of the preload consumption) through 120 minutes. Baseline is defined as the mean glucose over the 15 minutes prior to the preload consumption. Area falling below baseline will be excluded.

Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Postprandial Area Under the Curve to 180 Minutes
Délai: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Area under the curve above baseline from time zero (the start of the preload consumption) through 180 minutes. Baseline is defined as the mean glucose over the 15 minutes prior to the preload consumption. Area falling below baseline will be excluded.

Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Postprandial Area Under the Curve to 120 Minutes Relative to Start of the Meal
Délai: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Area under the curve above baseline from time zero (the start of the meal consumption) through 120 minutes. Baseline is defined as the mean glucose over the 15 minutes prior to the preload consumption. Area falling below baseline will be excluded.

Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Peak Glucose
Délai: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Maximum observed glucose peak over the course of the 180 minute window.

Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Incremental Peak Glucose
Délai: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Maximum observed glucose peak relative to baseline over the course of the 180 minute window.

Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Time to Peak
Délai: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Elapsed time from preload consumption to the maximum observed value.

Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Post-Meal Subjective State
Délai: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Fullness, hunger, energy, and gastrointestinal comfort on a 0-10 numerical rating scale with 10 being an optimal situation and 0 representing the inverse for fullness, energy, and gastrointestinal comfort and 0 being an optimal situation and 10 representing the inverse for hunger. Questions are asked 60 and 180 minutes after the start of the mixed meal.

Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Collaborateurs

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 (Réel)

9 novembre 2026

Achèvement primaire (Estimé)

15 janvier 2027

Achèvement de l'étude (Estimé)

1 mai 2027

Dates d'inscription aux études

Première soumission

19 octobre 2026

Première soumission répondant aux critères de contrôle qualité

19 octobre 2026

Première publication (Réel)

26 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 novembre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • LOA003

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

IPD is proprietary information.

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .