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

NCT06920641 | Completed

• 1 other identifier: PEP-2413
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tagatose; prebiotic; fecal microbiota; glucose; insulin; gut health; glycemic control

Outcome Measures

Primary Outcomes (1)

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

  Finger stick blood samples obtained fasted prior to consuming 50 grams of glucose. Six additional finger stick blood samples obtained over the next 2 hours beginning 15 minutes after consumption.

  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

Secondary Outcomes (1)

• Fecal microbiota composition

  Pre-dose baseline and Week 4 for each of two 4-week dosing periods

Other Outcomes (11)

• Fasting serum short-chain fatty acid (SCFA)

  Pre-dose baseline Day 1 and Day 29 of each of two 4-week dosing periods

• Fasting serum bile acids (BA)

  Pre-dose baseline Day 1 and Day 29 of each of two 4-week dosing periods

• Serum glucose total AUC 0-2 hours, peak concentrations and peak rises for glucose; glucose concentrations and increments at each time point over 2 hours

  Fasted at -5 minutes Time 0 pre-dose, post-dose 15, 30, 45, 60, 90 and 120 minutes post-dose.

Study Arms (2)

Tagatose

EXPERIMENTAL

10 grams tagatose

Other: Tagatose

Placebo

PLACEBO COMPARATOR

10 grams sucrose

Other: Placebo

Interventions

Tagatose OTHER

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)

Tagatose

Placebo OTHER

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)

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

INQUIS Clinical Research

Toronto, Ontario, M5C 2N8, Canada

Location

MeSH Terms

Conditions

Glucose Intolerance; Communicable Diseases; Insulin Resistance

Interventions

tagatose

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Study Officials

• Thomas MS Wolever, MD, PhD

  INQUIS Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 10, 2025
• Study Start: April 10, 2025
• Primary Completion: January 19, 2026
• Study Completion: January 19, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)