RecruitingNAINTERVENTIONAL

Effect of Chronic Exposure to Nextida GC-B on Glycemic Control in Adults With Normoglycemia or Prediabetes

This research study is investigating a new product called Nextida GC-B. We want to understand if it can help adults manage their blood sugar levels, especially those with normal blood sugar or who are at risk of developing type 2 diabetes (this is sometimes called prediabetes). The main goal is to see how Nextida GC-B compares to a dummy pill (placebo) in changing blood sugar levels after meals over 90 days. We're also looking at its safety. If you're an adult aged 18 or over with a BMI between 25 and 34.9, and either have normal blood sugar or prediabetes, you might be able to take part.

At a glance

Status

Recruiting

Phase

Sponsor

Rousselot BVBA

Enrolment target

Start

18 Feb 2026

Estimated completion

01 Aug 2026

Normoglycemia Prediabetes Glycemic Control

What is this study about?

This study is about a new product called Nextida GC-B. We want to find out if it can help people who have normal blood sugar levels or those who are at risk of developing type 2 diabetes. Being at risk, or having 'prediabetes', means your blood sugar levels are higher than normal, but not yet high enough to be diagnosed with type 2 diabetes. Managing blood sugar is really important for long-term health.

Type 2 diabetes is a condition where your body doesn't produce enough insulin or doesn't use insulin effectively. Insulin is a hormone that helps sugar (glucose) get into your cells to be used for energy. Over time, high blood sugar can lead to serious health problems. That's why researchers are constantly looking for new ways to help people keep their blood sugar levels in a healthy range.

In this study, we'll be comparing Nextida GC-B with a placebo. A placebo looks just like the study product but doesn't contain any active ingredients. This helps us to see if any changes we observe are truly due to Nextida GC-B or if they might happen naturally. We'll be focusing on how blood sugar levels change after meals over a period of 90 days. We'll also be carefully checking for any side effects to make sure Nextida GC-B is safe.

Key takeaways

This study tests a new product, Nextida GC-B, for blood sugar management.
It's for adults with normal blood sugar or prediabetes.
Compares Nextida GC-B to a dummy product (placebo).
Involves regular clinic visits and wearing a continuous glucose monitor.
Aims to understand safety and how it affects blood sugar after meals.
Participation lasts 90 days.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. We are looking for people whose body mass index (BMI) is between 25 and 34.9. You also need to have blood sugar levels that are either normal or show prediabetes. This means your HbA1c, which is a measure of your average blood sugar over a few months, should be 5.9% or less for normal levels, or between 6.0% and 6.4% for prediabetes.

For women who might get pregnant, you'll need to agree to use a reliable form of birth control throughout the study. If you've already gone through menopause or had a procedure like a hysterectomy, then this wouldn't apply to you. It's also important that your body weight has been stable for the last three months, meaning it hasn't changed by more than 5%. We also need you to be generally healthy and able to attend all clinic visits.

We would ask you to try and keep your usual habits, like your diet, exercise, and any medications or supplements you take, as consistent as possible during the study. This helps us to see the true effect of the product we are testing.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Is your BMI between 25 and 34.9?
Do you have normal blood sugar or prediabetes (HbA1c between 5.9% and 6.4%)?
Have you had a stable weight for the past 3 months?
Are you able to use reliable birth control if you could become pregnant?
Are you generally healthy and willing to attend all study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either Nextida GC-B or a placebo (a dummy product) to take. You won't know which one you are receiving. The study will last for a total of 90 days. During this time, you'll need to attend several clinic visits so our team can check your health, take blood samples, and measure your blood sugar levels, especially after meals.

We will also ask you to wear a Continuous Glucose Monitor (CGM) device. This is a small, discreet sensor that you wear on your skin, which automatically tracks your blood sugar levels throughout the day and night. You'll need to follow the instructions for using this device. We'll also ask you to complete some questionnaires, keep records, and fill out diaries about your experience. Your commitment to these tasks and attending all scheduled visits is important for the study's success.

Potential risks and benefits

Taking part in a study like this might have some potential benefits. For example, you'll receive regular health check-ups and close monitoring of your blood sugar levels. You might also gain a better understanding of your own health. The information we gather could help others in the future by contributing to new treatments. However, there's no guarantee that Nextida GC-B will improve your blood sugar or health. All medical procedures carry some risks, such as discomfort from blood tests or potential side effects from the study product, although these will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

KGK Science Inc.
Verified postcode
London, Canada· Recruiting

Common questions

What is 'prediabetes'?

Prediabetes means your blood sugar levels are higher than normal, but not yet high enough to be diagnosed with type 2 diabetes. It's a warning sign that you're at increased risk.

What is a placebo?

A placebo is a dummy treatment that looks exactly like the study product but contains no active ingredients. It helps us see if the real product is causing any effects.

Will I know if I'm getting the real product or the placebo?

No, this is a 'blinded' study. Neither you nor the study team will know if you're receiving Nextida GC-B or the placebo until after the study is complete.

What is a Continuous Glucose Monitor (CGM)?

A CGM is a small device you wear on your skin that continuously measures and records your blood sugar levels throughout the day and night.

How long will the study last if I join?

If you participate, the main study period will be for 90 days, which is about three months.

How to find out more

Marc Moulin, PhD

mmoulin@kgkscience.com 2267819094 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.