Nutritional Products for Glycemic Responses
(GLIN4 Trial)

Overseen ByDanone Nutricia Research

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Nutricia Research

Must not be taking: Adrenergic blockers, Diuretics

Disqualifiers: Diabetes, Gastrointestinal disease, Cancer, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different nutritional products affect blood sugar levels. Participants will try various products, including the concept product, with blood samples taken to assess each product's influence on blood sugar over a few hours. It suits individuals with a body mass index (BMI) between 18.5 and 27 who do not have diabetes or gastrointestinal issues. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

Will I have to stop taking my current medications?

Yes, if you are taking medications that affect carbohydrate metabolism, gastrointestinal function, or appetite, you must stop them at least 4 weeks before the screening visit.

What is the safety track record for these treatments?

Research shows that the product being tested examines how foods affect blood sugar levels. Foods with a low glycemic index (GI) cause a slower increase in blood sugar, while those with a high GI cause a quicker and higher spike.

Specific safety information for this product is not yet available. However, since this study is in Phase 4, the treatment has likely already received approval for some use. This phase usually indicates that the treatment is generally considered safe, but researchers are gathering more information on its effects.

If the product has been used before, it suggests it is generally well-tolerated. However, anyone considering joining the trial should consult their doctor to ensure it's the right choice for them.¹ ² ³ ⁴ ⁵

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the concept product for glycemic responses because it offers a fresh approach to managing blood sugar levels through nutritional interventions. Unlike traditional treatments that often rely on medications like insulin or metformin, this product focuses on using specifically formulated nutritional products to regulate blood sugar. This approach is promising because it might offer a more natural, non-pharmaceutical option for managing glycemic responses, potentially reducing side effects associated with standard medications. Furthermore, the randomized order of interventions in the trial aims to optimize the effectiveness of these nutritional products, making it an innovative step forward in dietary management for blood sugar control.

What evidence suggests that this trial's nutritional products could be effective for glycemic responses?

Research has shown that eating foods with a low glycemic index (GI) can lower blood sugar levels and improve markers of blood sugar control, which is especially important for people with type 2 diabetes. Studies have found that low-GI foods effectively manage blood sugar. Personalized diets, which predict how different foods affect an individual's blood sugar, have also shown promise. In this trial, participants will receive various nutritional products, including the concept product based on low-GI foods to manage blood sugar effectively. The order of these products will be randomized for each participant.⁶ ⁷ ⁸ ⁹ ¹⁰

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-65 with a BMI of 18.5 to 27. Participants should not have diabetes, gastrointestinal diseases, recent major trauma or surgery, cancer in the last two years (except non-melanoma skin cancer), or be on medications affecting carbohydrate metabolism.

Inclusion Criteria

Body mass index (BMI) between 18.5 and 27 kg/m²

Exclusion Criteria

My fasting blood sugar level was 6.1 or higher during the screening.

Known history of gastrointestinal disease, bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results

I haven't taken drugs affecting sugar levels, stomach function, or appetite in the last 4 weeks.

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume one serving of the reference product or the test product, with capillary blood samples taken at baseline and at several time-points over a 2-hour period

2 hours per visit

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

Concept product

Trial Overview

The study tests how different nutritional products affect blood sugar levels after fasting. Subjects will consume a serving of either a reference product or one of several test products and then have their blood sugar measured multiple times over two hours.