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

9 novembre 2026 aggiornato da: 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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • California
      • San Francisco, California, Stati Uniti, 94109
        • Reclutamento
        • Alethios
        • Contatto:
          • Zeenia Framroze
          • Numero di telefono: 650-206-8006

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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

Sperimentale: 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

Sperimentale: 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

Sperimentale: 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

Sperimentale: 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

Sperimentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postprandial Area Under the Curve to 120 Minutes
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postprandial Area Under the Curve to 180 Minutes
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 novembre 2026

Completamento primario (Stimato)

15 gennaio 2027

Completamento dello studio (Stimato)

1 maggio 2027

Date di iscrizione allo studio

Primo inviato

19 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

19 ottobre 2026

Primo Inserito (Effettivo)

26 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • LOA003

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

IPD is proprietary information.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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