CompletedNot Applicable

Effects of Tagatose on Glycemic Response and Gastrointestinal Microbiota in Healthy Adults

Canada59 participantsStarted 2025-04-10

Plain-language summary

The primary objective of this clinical-trial is to determine, in subjects with impaired fasting glucose (IFG) and/or insulin resistance (IR), if tagatose meets the definition of a prebiotic, namely that consuming tagatose for 4 weeks selectively stimulates the selective growth of bacteria in the colon and is associated with a health benefit (oral glucose tolerance) when compared to consuming the control treatment (10g sucrose) for 4 weeks.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, gastrointestin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in incremental area under the plasma glucose curve (ignoring area below the baseline, iAUC) over each 4-week intervention period

Timeframe: Before (-5 minutes and 0 minutes) and 15, 30, 45, 60, 90 and 120 minutes after overnight fasted subjects start to consume 50 grams of glucose on Day 1 and Day 29 of each of two 4-week intervention periods

Trial details

NCT IDNCT06920641

SponsorPepsiCo Global R&D

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-19

View on ClinicalTrials.gov More Glucose Intolerance trials