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Artificial sweeteners under scrutiny: could they worsen prediabetes?

NCT ID NCT05337098

Knowledge-focused Sponsor: Virginia Polytechnic Institute and State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether the artificial sweeteners aspartame and sucralose affect blood sugar control in adults aged 40 and older with prediabetes. Participants will receive either one of the sweeteners or a placebo as part of their diet for 8 weeks. Researchers will monitor blood sugar levels continuously and through glucose tolerance tests to see if these sweeteners impair glucose regulation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aspartame and sucralose (artificial sweeteners)
What this could lead to
If it works, this could show that certain artificial sweeteners harm blood sugar control in older adults with prediabetes, guiding safer dietary choices.
What could go wrong
This is a small, early-stage study with only 30 participants. Results may not apply to everyone, and the sweeteners may have no effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 40+ years * Prediabetic (fasting glucose concentration of 100-125 mg/dL, 2-hour oral glucose tolerance test glucose concentration of 140-199 mg/dL, or a HbA1c value of 5.7% to 6.4%) * Weight stable for previous 6 months (±2 kg) * BMI \<40 kg/m2 * Sedentary to recreationally active * No plans to gain/lose weight or change physical activity level * Willing to pick up food daily and consume foods provided for an 8-week period * Verbal and written informed consent * Approval by Medical Director * Consume less than one serving of non-nutritive sweetener per week Exclusion Criteria: * BMI \>40 kg/m2 * Diabetes or diabetes medication * Antibiotic, prebiotic or prebiotic use in prior 3 months * Uncontrolled hypertension (blood pressure (BP) \> 159/99 mmHg) * Diagnosed inflammatory bowel disease * Past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease * Vegetarian or vegan * Pregnant or plans to become pregnant * Breastfeeding * Food allergies or aversions, Phenylketonuria (PKU) * Estrogen or testosterone usage

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Conditions

The condition(s) this trial relates to.

Insulin Resistance prediabetes syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Continuous glucose monitoring Inflammatory markers Insulin sensitivity Oral glucose tolerance

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Virginia Tech

    RECRUITING

    Blacksburg, Virginia, 24061, United States

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