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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if tagatose, a sugar substitute, can improve blood sugar levels by promoting the growth of beneficial gut bacteria. Participants will receive either tagatose or a placebo (sugar) to assess any health benefits of tagatose. The trial seeks individuals with higher-than-normal glucose levels, who do not have diabetes, major health issues, or extreme dietary habits. Those who fit this profile may be suitable candidates for the trial. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on dietary interventions for blood sugar management.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that tagatose is generally safe for people. Studies have found no major health concerns with its use. A safety review found that people tolerate it well. In another study, participants reported no significant negative side effects when using tagatose to help manage blood sugar levels. Additionally, tagatose has a very low glycemic index, meaning it raises blood sugar more slowly than regular sugar. This makes it a promising option for those with blood sugar issues. Overall, evidence suggests that tagatose is safe for people, with minimal risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for impaired glucose tolerance, which often include lifestyle changes and medications like metformin, tagatose stands out because it uses a unique active ingredient: tagatose, a rare sugar. What makes tagatose exciting is that it may help manage blood sugar levels by being absorbed more slowly than regular sugars, potentially reducing the blood sugar spikes common with other carbohydrates. Researchers are eager to see if it offers a safer, more natural option for people with impaired glucose tolerance, with fewer side effects than traditional medications.

What evidence suggests that tagatose might be an effective treatment for impaired glucose tolerance?

Research has shown that tagatose might help control blood sugar. One study found that people who consumed tagatose had lower levels of hemoglobin A1c, which measures average blood sugar over time. Another study discovered that tagatose reduced blood sugar levels in people with high blood sugar after two hours. Tagatose is a sweetener that doesn't raise blood sugar like regular sugar does. In this trial, participants will receive either tagatose or a placebo to evaluate its effectiveness in managing blood sugar levels. These findings suggest that tagatose could benefit people with high blood sugar. ^{2 4 6 7 8}

Who Is on the Research Team?

Thomas MS Wolever, MD, PhD

Principal Investigator

INQUIS Clinical Research

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4820068/

Safety and Efficacy of D-Tagatose in Glycemic Control ... Here we report the results of a phase 3 clinical trial with D-tagatose and demonstrate statistically significant reductions in hemoglobin A1c levels (HbA1c) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06920641?cond=Tagatose&viewType=Table&rank=3

Effects of Tagatose on Glycemic Response and ... The primary objective of this clinical-trial is to determine, in subjects with impaired fasting glucose (IFG) and/or insulin resistance (IR), if tagatose ...

3. fda.gov fda.gov/media/176463/download

Petition for a Qualified Health Claim for D-Tagatose and ... FDA identified incidence of type 2 diabetes16 and the following surrogate endpoints as appropriate to use in identifying type 2 diabetes risk ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2018/8718053

D‐Tagatose Is a Promising Sweetener to Control ... After the intake of a beverage with tagatose (5 g), only hyperglycemic individuals had a significant reduction of blood glucose at 120 min (P = ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5818958/

D-Tagatose Is a Promising Sweetener to Control Glycaemia Recent studies indicate that tagatose has a powerful antidiabetic effect and could eventually be associated with important benefits for the treatment of obesity ...

6. fda.gov fda.gov/media/155246/download

GRAS Notice 977, D-tagatose Therefore, the safety data presented in these notices is also ... “Human Gastrointestinal Tolerance to D-Tagatose.” Regulatory Toxicology ...

7. foodstandards.gov.au foodstandards.gov.au/sites/default/files/publications/Documents/29_D-tagatose.pdf

D-TAGATOSE A Human Health Risk Assessment On the basis of the available animal and human safety data on D-tagatose, there are no public health and safety concerns associated with use of D-tagatose for ...

8. sciencedirect.com sciencedirect.com/topics/medicine-and-dentistry/tagatose

Tagatose - an overview It has a glycemic index of only 3 compared to 100 for glucose. Its glycemic index is markedly lower than those for other natural sugars and most sugar alcohols.