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

NCT06920641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

  • Glucose Intolerance
  • Microbial Colonization

Interventions

OTHER

Tagatose

Sachet containing 10g tagatose to be dissolved in 250ml water and taken once daily on Days 1-28 of a 4-week dosing period. (1 of 2 dosing periods separated by a 4-week washout)

OTHER

Placebo

Sachet containing 10g sucrose to be dissolved in 250ml water and taken once daily on Days 1-28 of a 4-week dosing period. (1 of 2 dosing periods separated by a 4-week washout)

Sponsors & Collaborators

  • PepsiCo Global R&D

    lead INDUSTRY

Principal Investigators

  • Thomas MS Wolever, MD, PhD · INQUIS Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2026-01-19
Completion
2026-01-19

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06920641 on ClinicalTrials.gov