Glin4: Assessment of the Glycemic Responses to Nutritional Products (GLIN4)
Status and phase
Completed
Phase 4
Conditions
Glycemic Response
Treatments
Dietary Supplement: First Concept product
Dietary Supplement: Seventh Concept product
Dietary Supplement: Second Concept product
Dietary Supplement: Second reference product
Dietary Supplement: Third reference product
Dietary Supplement: First Reference product
Dietary Supplement: Sixth Concept product
Dietary Supplement: Fifth Concept product
Dietary Supplement: Fourth Concept product
Dietary Supplement: Third Concept product
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 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
- Baseline fasting Glucose ≥6.1 at screening visit
- 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
Diagnostic
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
12 participants in 10 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
Arm 6
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
Arm 7
Other group
Description:
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Treatment:
Dietary Supplement: Fourth Concept product
Arm 8
Other group
Description:
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Treatment:
Dietary Supplement: Fifth Concept product
Arm 9
Other group
Description:
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Treatment:
Dietary Supplement: Sixth Concept product
Arm 10
Other group
Description:
All subjects will receive all interventions during the trial. The order of the Nutritional products will be randomized.
Treatment:
Dietary Supplement: Seventh Concept product
Trial contacts and locations
1
Loading...
Central trial contact
Danone Nutricia Research
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems