Recruiting

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

Sponsor:

LOAM Science

Code:

NCT07895628

Conditions

Postprandial Glucose

GI Tolerance

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

LOAM Fiber-based Sweetener

Sugar

Stevia

Study Details

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.

Conditions

Postprandial Glucose

GI Tolerance

Study ID

NCT07895628

Start date

Nov 9, 2026

Status verified date

Oct, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science