Assessment of the Glycemic Responses to Nutritional Products-INQ-2526 (GLIN#5)

Nutricia

Status: Completed

Conditions: Glycemic Response

Treatments: Dietary Supplement: Third Reference Product; Dietary Supplement: Second Concept Product; Dietary Supplement: First Reference Product; Dietary Supplement: Second Reference Product; Dietary Supplement: First Concept Product

Study type: Interventional

Funder types: Industry

Identifiers

NCT07243743

25REX0091089 - GLIN#5

Details and patient eligibility

About

This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume a 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 and ≤ 65 years
2. Body mass index (BMI) between 18.5 and 27 kg/m²

Exclusion criteria

1. Fasting Glucose ≥6.1 at screening visit
2. 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.
3. Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication 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.
4. Major trauma or surgical event within 3 months of screening.
5. Known intolerance, sensitivity or allergy to test products.
6. Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
7. History of cancer in the prior two years, except for non-melanoma skin cancer.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

14 participants in 5 patient groups

Arm 1

Other group

Description:

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

Treatment:

Dietary Supplement: First Reference Product

Arm 2

Other group

Description:

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

Treatment:

Dietary Supplement: Second Reference Product

Arm 3

Other group

Description:

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

Treatment:

Dietary Supplement: Third Reference Product

Arm 4

Other group

Description:

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

Treatment:

Dietary Supplement: First Concept Product

Arm 5

Other group

Description:

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

Treatment:

Dietary Supplement: Second Concept Product