Postprandial Glucose, GI Tolerance
Conditions
Keywords
Fiber, Postprandial Glucose Response, Sweetener
Brief summary
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.
Interventions
Sponsors
LOAM Science
Alethios, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Three different interventions (sugar, stevia, and a fiber-based sugar alternative) of comparable sweetness will be evaluated in a randomized order.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Area Under the Curve to 120 Minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Area Under the Curve to 180 Minutes | 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. |
| Post-Meal Subjective State | 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. |
| Peak Glucose | 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. |
| Incremental Peak Glucose | 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. |
| Time to Peak | 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. |
| Postprandial Area Under the Curve to 120 Minutes Relative to Start of the Meal | 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. |
Contacts
CONTACTJohn B Jarman, PhD
Outcome results
None listed