Assessment of the Glycemic Responses to Nutritional Products (v2.0) (GLIN#2)

Nutricia

Status: Unknown

Conditions: Glycemic Response

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05308147

INQ-2137 v2.0

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.
• 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.
• Major trauma or surgical event within 3 months of screening.
• Known intolerance, sensitivity or allergy to test products.
• Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
• 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)

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12 participants in 6 patient groups

Arm 1 (Reference)

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 (Reference)

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 (Reference)

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 (Concept)

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 (Concept)

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

Arm 6 (Concept)

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 Concept product