Postprandial GlucoseNCT07895628
A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting
A study testing LOAM Fiber-based Sweetener, Sugar and Stevia in people with Postprandial Glucose and GI Tolerance, run by LOAM Science.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postprandial Glucose, GI Tolerance
- What is being tested?
- LOAM Fiber-based Sweetener, Sugar and Stevia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Postprandial Glucose, GI Tolerance
- Being tested
- LOAM Fiber-based Sweetener, Sugar, Stevia
- Keywords
- Fiber, Postprandial Glucose Response, Sweetener
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOAM Fiber-based SweetenerDietary supplement
A fiber-based sweetener produced by LOAM.
SugarOther
Table sugar
SteviaOther
Stevia
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order. Receives: Dietary Supplement: LOAM Fiber-based Sweetener; Other: Sugar; Other: Stevia |
| Sequence 2 | Experimental | Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order. Receives: Dietary Supplement: LOAM Fiber-based Sweetener; Other: Sugar; Other: Stevia |
| Sequence 3 | Experimental | Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order. Receives: Dietary Supplement: LOAM Fiber-based Sweetener; Other: Sugar; Other: Stevia |
| Sequence 4 | Experimental | Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order. Receives: Dietary Supplement: LOAM Fiber-based Sweetener; Other: Sugar; Other: Stevia |
| Sequence 5 | Experimental | Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order. Receives: Dietary Supplement: LOAM Fiber-based Sweetener; Other: Sugar; Other: Stevia |
| Sequence 6 | Experimental | Sugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order. Receives: Dietary Supplement: LOAM Fiber-based Sweetener; Other: Sugar; Other: Stevia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Area Under the Curve to 120 Minutes
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.
Measured: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Secondary outcomes (6)
Postprandial Area Under the Curve to 180 Minutes
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.
Measured: 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
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.
Measured: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Peak Glucose
Maximum observed glucose peak over the course of the 180 minute window.
Measured: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Incremental Peak Glucose
Maximum observed glucose peak relative to baseline over the course of the 180 minute window.
Measured: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Time to Peak
Elapsed time from preload consumption to the maximum observed value.
Measured: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Post-Meal Subjective State
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.
Measured: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postprandial GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Three different interventions (sugar, stevia, and a fiber-based sugar alternative) of comparable sweetness will be evaluated in a randomized order.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LOAM Science
- Sponsor type
- University, hospital or other
- Collaborators
- Alethios, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895628
- Sponsor's protocol ID
- LOA003
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is proprietary information.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Participant-Masked, Crossover Study Evaluating Postprandial Glycemic Response to Three Sweetener Preloads Consumed Before a Standardized Mixed Meal in Healthy Adults
- ClinicalTrials.gov ID
- NCT07895628
- Acronym / sponsor ID
- LOA003
- Conditions
- Postprandial Glucose, GI Tolerance
- Keywords
- Fiber, Postprandial Glucose Response, Sweetener
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- LOAM ScienceUniversity, hospital or other
- Collaborators
- Alethios, Inc.
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Three different interventions (sugar, stevia, and a fiber-based sugar alternative) of comparable sweetness will be evaluated in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Dietary Supplement: LOAM Fiber-based Sweetener, Other: Sugar, Other: SteviaSugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order. |
| Sequence 2 | Experimental | Dietary Supplement: LOAM Fiber-based Sweetener, Other: Sugar, Other: SteviaSugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order. |
| Sequence 3 | Experimental | Dietary Supplement: LOAM Fiber-based Sweetener, Other: Sugar, Other: SteviaSugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order. |
| Sequence 4 | Experimental | Dietary Supplement: LOAM Fiber-based Sweetener, Other: Sugar, Other: SteviaSugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order. |
| Sequence 5 | Experimental | Dietary Supplement: LOAM Fiber-based Sweetener, Other: Sugar, Other: SteviaSugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order. |
| Sequence 6 | Experimental | Dietary Supplement: LOAM Fiber-based Sweetener, Other: Sugar, Other: SteviaSugar, stevia, and a fiber-based alternative sweetener will be evaluated in a pre-defined order. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOAM Fiber-based SweetenerA fiber-based sweetener produced by LOAM. | Dietary supplement | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| SugarTable sugar | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
| SteviaStevia | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Postprandial Area Under the Curve to 120 Minutes
Time frame: 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.
6 secondary outcomes
Postprandial Area Under the Curve to 180 Minutes
Time frame: 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
Time frame: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Peak Glucose
Time frame: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Incremental Peak Glucose
Time frame: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Time to Peak
Time frame: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Post-Meal Subjective State
Time frame: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. IPD is proprietary information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing LOAM Fiber-based Sweetener, Sugar and Stevia in people with Postprandial Glucose and GI Tolerance, run by LOAM Science.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John B Jarman, PhD (323-325-1327, bryce@loamscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial Area Under the Curve to 120 Minutes (time frame: Data will be collected on each day of supplementation, days 3, 4, 6, 7, 9, and 10.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.