Tagatose for Impaired Glucose Tolerance

Overseen By Janice Campbell

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: PepsiCo Global R&D

Must not be taking: Hypoglycemics, GLP-I agonists, Steroids, Antipsychotics

Disqualifiers: Diabetes, IBS, IBD, Pregnancy, others

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

55 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those using certain medications like hypoglycemic agents and systemic steroids. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Tagatose for impaired glucose tolerance?

Research shows that Tagatose can help lower blood sugar levels after meals in people with high blood sugar, and it may also aid in weight loss and improve cholesterol levels in people with type 2 diabetes. These effects suggest it could be beneficial for managing impaired glucose tolerance. ^{1 2 3 4 5}

How is the drug Tagatose different from other treatments for impaired glucose tolerance?

Tagatose is unique because it is a naturally occurring sugar that can help manage blood sugar levels without the risk of causing euglycemic diabetic ketoacidosis, a rare but serious side effect associated with some other diabetes medications like SGLT2 inhibitors. ^{6 7 8 9 10}

Research Team

Thomas MS Wolever, MD, PhD

Principal Investigator

INQUIS Clinical Research

Eligibility Criteria

Healthy adults aged 18-50 with a BMI of 20.0 to 34.9, not diabetic, and have fasting glucose levels slightly elevated but below the diabetes threshold can join this trial. They mustn't change their diet except for avoiding certain foods like those with added probiotics or fermented items.

Inclusion Criteria

BMI 20.0 to 34.9 kg/m², inclusive

Fasting serum glucose <7.0 mmol/L

Systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg

Exclusion Criteria

Failure to meet any one of the inclusion criteria

Reported history of various medical conditions that increase risk or may affect results

Extreme dietary habits

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 10 grams of tagatose or 10 grams of sucrose for 4 weeks in a crossover design

4 weeks

2 visits (in-person) at Day 1 and Day 29 of each dosing period

Crossover Treatment

Participants switch to the alternate treatment (tagatose or sucrose) for another 4 weeks

4 weeks

2 visits (in-person) at Day 1 and Day 29 of each dosing period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tagatose

Trial Overview The study is testing if Tagatose, a sweetener, acts as a prebiotic by improving gut bacteria and blood sugar control over four weeks compared to sucrose (sugar). Participants will be randomly given either Tagatose or a placebo.

Participant Groups

Group I: Tagatose Experimental Treatment 1 Intervention

10 grams tagatose

Group II: Placebo Placebo Group 1 Intervention

10 grams sucrose

Who Is Running the Clinical Trial?

PepsiCo Global R&D

Lead Sponsor

Trials

99

Recruited

13,600+

Ramon Laguarta

PepsiCo Global R&D

Chief Executive Officer since 2018

MBA from ESADE Business School

Mark Kirkham

PepsiCo Global R&D

Chief Marketing Officer

Bachelor's degree in Business Administration from Trinity College Dublin

References

1. United States pubmed.ncbi.nlm.nih.gov

Dietary supplementation with d-tagatose in subjects with type 2 diabetes leads to weight loss and raises high-density lipoprotein cholesterol. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Tagatose, a new antidiabetic and obesity control drug. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of D-Tagatose in Glycemic Control in Subjects with Type 2 Diabetes. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Beneficial effect of tagatose consumption on postprandial hyperglycemia in Koreans: a double-blind crossover designed study. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Tagatose: from a sweetener to a new diabetic medication? [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Euglycemic diabetic ketoacidosis: A rare but serious side effect of sodium-glucose co-transporter 2 inhibitors. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

Sodium-glucose cotransporter 2 inhibitors improved time-in-range without increasing hypoglycemia in Japanese patients with type 1 diabetes: A retrospective, single-center, pilot study. [2022]

8. France pubmed.ncbi.nlm.nih.gov

[Diabetic euglycemic ketosis or ketoacidosis in individuals with type 2 diabetes treated by SGLT2 inhibitors: A series of Belgian clinical cases]. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

SGLT2 Inhibition in Type 1 Diabetes with Diabetic Kidney Disease: Potential Cardiorenal Benefits Can Outweigh Preventable Risk of Diabetic Ketoacidosis. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

SGLT2 Inhibitor-Induced Euglycemic Diabetic Ketoacidosis: A Case Report. [2020]