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

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), inclusiveand/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/orpostbiotics, fermented foods (e.g., yogurt, sauerkraut, kombucha), and dietarysupplements containing fiber, probiotics, prebiotics, synbiotics, and/or postbioticsfor at least 2 weeks before Week 0 (Day 1) and throughout the duration of theirparticipation in the study

• Modified TAPS (tobacco, alcohol, prescription medications and other substances) toolresponses are within allowable usage limits

• Ability to understand the study procedures and willing to provide informed consentto participate in the study

• Subjects must be eligible to receive income in Canada and be covered by a healthinsurance 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 conditionsthat, in the judgment of the Principal Investigator, increase the risk to thesubject 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 judgedby 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 thesubject or others or may affect results, as judged by the Principal Investigator.

• Current diagnosis or history of irritable bowel syndrome (IBS), inflammatory boweldisease (IBD, including ulcerative colitis and Crohn's disease), functionalconstipation (defined by the Rome IV diagnostic criteria 1-8, diarrhea (loose orwatery stools for the last 3 months without abdominal pain or bothersome bloating inmore than 25% of stools), celiac disease, lactose intolerance and/or malabsorption,gastroparesis, gastroenteritis, endometriosis, diverticulosis, gastric or duodenalulcers, pancreatitis, or eating disorder; history of intestinal surgery (excludingappendectomy or herniorrhaphy), or history of bariatric surgery.

• Extreme dietary habits, including but not limited to intentional consumption of anextremely 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 andjuice) on average per day (note: not including sweetened tea/coffee)

• Known intolerance, sensitivity, or allergy to any ingredients in the study testproducts

• Self-reported pregnancy or breastfeeding or planning to become pregnant.

• Participation in any clinical trial within the past 30 days or any PepsiCo protocolwithin the past 6 months.

• Subjects who, in the opinion of the investigator, are unable or unlikely to complywith the dosing schedule and study evaluations.