Status:
RECRUITING
Effects of Tagatose on Glycemic Response and Gastrointestinal Microbiota in Healthy Adults
Lead Sponsor:
PepsiCo Global R&D
Conditions:
Glucose Intolerance
Microbial Colonization
Eligibility:
All Genders
18-50 years
Phase:
NA
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 th...
Detailed Description
Available evidence suggests that tagatose may act as a prebiotic compound. It has been hypothesized that undigested tagatose reaches the colon and is fermented by colonic bacteria, resulting in the pr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT06920641
Start Date
March 25 2025
End Date
December 31 2025
Last Update
April 10 2025
Active Locations (1)
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1
INQUIS Clinical Research
Toronto, Ontario, Canada, M5C 2N8