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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+