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

Launched by PEPSICO GLOBAL R&D · Apr 1, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a sweetener called tagatose on blood sugar levels and gut bacteria in healthy adults who may have slightly elevated blood sugar or insulin resistance. Over the course of four weeks, participants will either consume tagatose or a control sweetener, and researchers will look to see if tagatose helps improve how the body responds to sugar and promotes the growth of healthy bacteria in the gut.

To be eligible for this study, participants should be healthy adults aged 18 to 50 with a body mass index (BMI) between 20 and 34.9, and they should have a fasting blood sugar level that is not too high. Participants will need to avoid certain foods and supplements during the study, and they should not have any serious medical issues that could affect the results. Those who join the trial will help researchers learn more about tagatose and its potential health benefits, and they will receive guidance throughout their participation.

Gender

ALL

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.