Nutritional Products for Glycemic Responses
(GLIN#5 Trial)

Overseen ByDanone Nutricia Research

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nutricia Research

Must not be taking: Adrenergic blockers, Diuretics, others

Disqualifiers: Diabetes, Gastrointestinal disease, others

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

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 several products, including the First Concept Product, and researchers will check their blood sugar at various times after eating. This opportunity suits individuals not on medications affecting blood sugar and with a body mass index (BMI) between 18.5 and 27 kg/m². Those without diabetes or certain medical conditions and not following a special diet may find this trial suitable. As an unphased trial, it offers a unique chance to contribute to nutritional science and potentially improve dietary recommendations.

Will I have to stop taking my current medications?

Yes, you will need to stop taking medications that affect carbohydrate metabolism, gastrointestinal function, or appetite, like adrenergic blockers, diuretics, and metformin, at least 4 weeks before the screening visit.

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

Studies have shown that eating foods with a low glycemic index (GI) can help maintain steady blood sugar levels over time. Stable blood sugar is important because it can lower the risk of diabetes-related complications. Research on the glycemic index often examines how different foods affect blood sugar after consumption.

For the First Concept Product, research suggests that foods with a lower GI are generally gentle on the body. No significant reports of negative effects from these foods indicate that the product is likely safe for blood sugar levels.

Regarding the Second Concept Product, studies also show that foods causing lower blood sugar spikes are safe. Again, no major reports of issues arise when people consume these foods, suggesting the product is likely safe for consumers.

Overall, both nutritional products appear well-tolerated based on existing research. However, individual experiences may vary, and consulting a healthcare provider before joining any study is always advisable.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different nutritional products can influence glycemic responses, a key factor in managing blood sugar levels. Unlike traditional treatments for blood sugar control, which often involve medications or insulin injections, these nutritional products offer a non-invasive approach. By testing several concept and reference nutritional products, the trial aims to identify specific products that could provide better blood sugar stability. This could lead to new dietary strategies for managing conditions like diabetes, offering a potential alternative or complement to existing medical treatments.

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

Studies have shown that eating foods with a low glycemic index (GI) can help manage type 2 diabetes. The GI measures how quickly foods raise blood sugar levels. In this trial, participants will receive the First Concept Product, designed to have a low GI, making it a promising option for controlling blood sugar. Research also indicates that foods with a low glycemic load (GL), which considers both the GI and the amount of carbohydrates, can effectively help manage diabetes.

Participants will also receive the Second Concept Product during the trial. Research has shown that special nutrition formulas, like the Second Concept Product, can help control how much and how fast blood sugar rises after eating. While individual responses to these formulas can vary, they generally help maintain stable blood sugar levels. Both products aim to help people manage their blood sugar levels better by using the principles of GI and GL.² ³ ⁶ ⁷ ⁸

Are You a Good Fit for This Trial?

This trial is for individuals who can participate in a study assessing blood sugar responses after consuming nutritional products. Participants will need to fast before testing and provide blood samples over a two-hour period.

Inclusion Criteria

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

I am between 18 and 65 years old.

Exclusion Criteria

I have not had major surgery or a serious injury in the last 3 months.

I haven't taken any medication that affects sugar levels, stomach function, or appetite in the last 4 weeks.

Known intolerance, sensitivity or allergy to test products

See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume a serving of the reference product or the test product, with capillary blood samples taken at baseline and 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

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

First Concept Product
First Reference Product
Second Concept Product
Second Reference Product
Third Reference Product

Trial Overview

The study is looking at how different nutritional products affect blood sugar levels. Subjects will consume either a reference product or one of the test products, with their glycemic response monitored through capillary blood tests.