A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting
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.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: John B Jarman, PhD
- Numer telefonu: 323-325-1327
- E-mail: bryce@loamscience.com
Lokalizacje studiów
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California
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San Francisco, California, Stany Zjednoczone, 94109
- Rekrutacyjny
- Alethios
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Kontakt:
- Zeenia Framroze
- Numer telefonu: 650-206-8006
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Potroić
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
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Eksperymentalny: 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 |
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Eksperymentalny: 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 |
|
Eksperymentalny: 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 |
|
Eksperymentalny: 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 |
|
Eksperymentalny: 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 |
|
Eksperymentalny: 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 |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Postprandial Area Under the Curve to 120 Minutes
Ramy czasowe: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
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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.
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Postprandial Area Under the Curve to 180 Minutes
Ramy czasowe: 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.
|
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Postprandial Area Under the Curve to 120 Minutes Relative to Start of the Meal
Ramy czasowe: 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.
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Peak Glucose
Ramy czasowe: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
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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.
|
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Incremental Peak Glucose
Ramy czasowe: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
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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.
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Time to Peak
Ramy czasowe: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
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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.
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Post-Meal Subjective State
Ramy czasowe: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
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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.
|
Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- LOA003
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
IPD is proprietary information.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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