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Sweetener tagatose may tame blood sugar and feed good gut bugs

NCT ID NCT06920641

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether tagatose, a low-calorie sweetener, can act as a prebiotic—meaning it selectively feeds beneficial gut bacteria and improves blood sugar control. Fifty-nine healthy adults with slightly high blood sugar or insulin resistance took either tagatose or a placebo (sucrose) daily for four weeks, then switched after a break. Researchers measured blood sugar responses and gut bacteria changes to see if tagatose offers a health benefit beyond just sweetening.

What this could mean

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

Active substance
tagatose
What this could lead to
If tagatose is shown to be a prebiotic, it could point toward a sugar substitute that also supports healthy blood sugar and gut bacteria.
What could go wrong
This is a small, early-stage study in healthy adults, not people with diabetes. The results may not apply to the general population, and tagatose may not prove effective.

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

59 people

The number who actually took part.

Started

Apr 2025

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Healthy individuals aged 18-50 years, inclusive * BMI 20.0 to 34.9 kg/m², inclusive * Fasting serum glucose \<7.0 mmol/L * Fasting serum glucose between 6.1 and 6.9 mmol/L (110 to 124 mg/dL), inclusive and/or fasting insulin \>50th percentile (\>43 pmol/L = \>7.2 μU/mL) * No history of diabetes mellitus * Systolic blood pressure \<160 mmHg and diastolic blood pressure \<100 mmHg * Agree not to change current dietary habits with the exception of the following: agreement to avoid foods/drinks with added probiotics, prebiotics, and/or postbiotics, fermented foods (e.g., yogurt, sauerkraut, kombucha), and dietary supplements containing fiber, probiotics, prebiotics, synbiotics, and/or postbiotics for at least 2 weeks before Week 0 (Day 1) and throughout the duration of their participation in the study * Modified TAPS (tobacco, alcohol, prescription medications and other substances) tool responses are within allowable usage limits * Ability to understand the study procedures and willing to provide informed consent to participate in the study * Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as OHIP * Subjects are willing to sign the informed consent prior to any procedures conducted Exclusion Criteria: * Failure to meet any one of the inclusion criteria * Reported history of metabolic (including type 1 and type 2 diabetes mellitus), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, psychiatric disorders, or any other medical conditions that, in the judgment of the Principal Investigator, increase the risk to the subject or others or may affect results. * Antibiotic use within 60 days before randomization * Hospital admission for major trauma, or major medical or surgical event, as judged by the Principal Investigator, within 6 months of screening. * Use of medications such as, but not limited to, hypoglycemic agents, GLP-I agonists, systemic steroids, antipsychotics, or any others that increase the risk to the subject or others or may affect results, as judged by the Principal Investigator. * Current diagnosis or history of irritable bowel syndrome (IBS), inflammatory bowel disease (IBD, including ulcerative colitis and Crohn's disease), functional constipation (defined by the Rome IV diagnostic criteria 1-8, diarrhea (loose or watery stools for the last 3 months without abdominal pain or bothersome bloating in more than 25% of stools), celiac disease, lactose intolerance and/or malabsorption, gastroparesis, gastroenteritis, endometriosis, diverticulosis, gastric or duodenal ulcers, pancreatitis, or eating disorder; history of intestinal surgery (excluding appendectomy or herniorrhaphy), or history of bariatric surgery. * Extreme dietary habits, including but not limited to intentional consumption of an extremely high fiber diet (e.g., \>50g per day), gluten-free, low-carb, vegan, ketogenic, low FODMAP. * Consumption of \>2 sugar sweetened or artificially sweetened beverages (soda and juice) on average per day (note: not including sweetened tea/coffee) * Known intolerance, sensitivity, or allergy to any ingredients in the study test products * Self-reported pregnancy or breastfeeding or planning to become pregnant. * Participation in any clinical trial within the past 30 days or any PepsiCo protocol within the past 6 months. * Subjects who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • INQUIS Clinical Research

    Toronto, Ontario, M5C 2N8, Canada

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