Nutritional Products for Glycemic Responses

(GLIN4 Trial)

Overseen By Danone 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 Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 hours per visit

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.

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.

How Is the Trial Designed?

Group I: Arm 9 Experimental Treatment 1 Intervention

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group II: Arm 8 Experimental Treatment 1 Intervention

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group III: Arm 7 Experimental Treatment 1 Intervention

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group IV: Arm 6 Experimental Treatment 1 Intervention

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group V: Arm 5 Experimental Treatment 1 Intervention

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group VI: Arm 4 Experimental Treatment 1 Intervention

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group VII: Arm 3 Experimental Treatment 1 Intervention

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group VIII: Arm 2 Experimental Treatment 1 Intervention

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group IX: Arm 10 Experimental Treatment 1 Intervention

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Group X: Arm 1 Experimental Treatment 1 Intervention

All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.

Who Is Running the Clinical Trial?

Nutricia Research

Lead Sponsor

Trials

52

Recruited

7,200+

INQUIS Clinical Research

Industry Sponsor

Trials

12

Recruited

400+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523234681

Glycemic response and health—a systematic review ... Data from 45 relevant publications were found to January 2005. Lower glycemic index (GI) diets reduced both fasting blood glucose and glycated proteins ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6484621/

Assessment of a Personalized Approach to Predicting ... This cohort study using a personalized predictive model describes and predicts the glycemic responses of individuals without diabetes to a diverse array of ...

3. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(23)23462-0/fulltext

Glycemic response and health: summary of a workshop This article reports the proceedings of a workshop at which a meta-analysis of the relation between the glycemic response to foods and health was presented and ...

4. medrxiv.org medrxiv.org/content/10.1101/2024.04.12.24305746v1.full-text

A New Approach to Personalized Glycemic Control We evaluated: the algorithm's performance using simulated data with known glycemic control outcomes; the algorithm's ability to accurately ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4994556/

The concept of low glycemic index and glycemic load foods ... This article examines the concepts of low glycemic indices (GIs) and glycemic load (GL) foods as key drivers in the dietary management of type 2 diabetes as ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8466312/

Dietary Glycaemic Index Labelling: A Global Perspective The glycaemic index (GI) is a food metric that ranks the acute impact of available (digestible) carbohydrates on blood glucose.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0939475315001271

Glycemic index, glycemic load and glycemic response: An ... Foods having carbohydrate that is digested, absorbed and metabolized quickly are considered high GI foods (GI ≥ 70 on the glucose scale) whereas those that are ...

8. researchgate.net researchgate.net/publication/5673959_The_glycemic_index_concept_in_action

(PDF) The glycemic index concept in action The aim of this summary is to show how the glycemic concept is being used by the food manufacturing industry, how it is perceived and understood ...

9. mdpi.com mdpi.com/2304-8158/10/11/2626

Development of a Prediction Model to Estimate the ... This study aimed to investigate the glycemic response after consuming commercially purchased ready-to-eat meal and to develop the GL prediction formula.

10. caloriecontrol.org caloriecontrol.org/glycemic-response/

Glycemic Response The glycemic index (GI) concept was developed as a way to rank carbohydrate-containing foods based on their potential to raise blood glucose.