Effects of tagatose on blood sugar and gut bacteria in healthy adults

Effects of Tagatose on Glycemic Response and Gastrointestinal Microbiota: A Randomized, Placebo-Controlled, Double-Blind, Crossover Trial in Healthy Adults

This study is testing if tagatose can help healthy adults with blood sugar control and improve their gut bacteria compared to regular sugar.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: PepsiCo Global R&D (Industry-sponsored)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06920641 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of tagatose, a potential prebiotic, on glycemic response and gut microbiota in healthy adults with impaired fasting glucose or insulin resistance. Participants will consume either tagatose or a control treatment (sucrose) for four weeks in a double-blind, randomized, controlled, cross-over design. The study aims to determine if tagatose selectively stimulates beneficial gut bacteria and improves glycemic control compared to the control. The trial will recruit 55 healthy adults aged 18-50 with specific eligibility criteria related to glucose levels and dietary habits.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-50 with impaired fasting glucose or hyperinsulinemia.

Not a fit: Patients with a history of diabetes mellitus or those outside the specified age and BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new dietary approach to improve glycemic control in individuals with glucose intolerance.

How similar studies have performed: While limited clinical trials have explored tagatose's effects, the approach of using prebiotics for glycemic control is supported by preclinical evidence, making this study a novel exploration.

Eligibility criteria

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.

Where this trial is running

Toronto, Ontario

• INQUIS Clinical Research — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Thomas MS Wolever, MD, PhD — INQUIS Clinical Research
• Study coordinator: Janice Campbell

Conditions Glucose Intolerance; Microbial Colonization; tagatose; prebiotic; fecal microbiota; glucose; insulin; gut health