Clinical trial NCT06797349: Glin4: Assessment of the Glycemic Responses to Nutritional Products
Official title: Determination of the Postprandial Glycemic Response and Glycemic Index of Nutritional Products: A Randomized Controlled Clinical Trial in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glycemic Response
Keywords: Glycemic response
Glycemic Index
Nutritional products
Healthy Individuals
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
Collaborators: name: INQUIS Clinical Research
First posted: 2025-01-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 10 products will be tested (7 test products and 3 controls)
Primary purpose: DIAGNOSTIC

Brief summary: 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: Inclusion Criteria:

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

Exclusion Criteria:

1. Baseline 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.

Primary outcomes:
measure: The glycemic index of nutritional products
timeFrame: from enrollment to the end of treatment at about 9 weeks
Secondary outcomes:
measure: 1. The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references
timeFrame: from enrollment to the end of treatment at about 9 weeks
measure: 2. The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references
timeFrame: from enrollment to the end of treatment at about 9 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: INQUIS Clinical Research, Ltd , 20 Victoria Street, 3rd Floor
state: Ontario
Study officials:
References: