Glycemic Response
Conditions
Keywords
Glycemic response, Glycemic index, Nutritional products, Healthy individuals
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.
Interventions
DIETARY_SUPPLEMENTSecond Reference product (dextrose, containing 25 g of carbohydrates)
Reference dextrose solution containing 25 g of available carbohydrates
DIETARY_SUPPLEMENTFirst Reference product (dextrose, containing 25 g of carbohydrates)
Reference dextrose solution containing 25 g of available carbohydrates
DIETARY_SUPPLEMENTThird Reference product (dextrose, containing 25 g of carbohydrates)
Reference dextrose solution containing 25 g of available carbohydrates
DIETARY_SUPPLEMENTHigh protein tube feed
Nutritional product containing 25 g of available carbohydrates
DIETARY_SUPPLEMENTHigh-protein tube feed with additional amino acid
Nutritional product containing 25 g of available carbohydrates
DIETARY_SUPPLEMENTOral Nutritional Supplement for diabetes patients
Nutritional product containing 25 g of available carbohydrates
DIETARY_SUPPLEMENTOral Nutritional Supplement for diabetes patients (new formula)
Nutritional product containing 25 g of available carbohydrates
DIETARY_SUPPLEMENTONS for disease related malnutrition
Nutritional product containing 25 g of available carbohydrates
DIETARY_SUPPLEMENTPlantbased ONS for disease related malnutrition
Nutritional product containing 25 g of available carbohydrates
Sponsors
INQUIS Clinical Research
Nutricia Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The glycemic index of nutritional products | 9 test days (test days will be separated by at least 1 day in between tests for each participant) |
Secondary
| Measure | Time frame |
|---|---|
| The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references | 9 test days (test days will be separated by at least 1 day in between tests for each participant) |
| The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references | 9 test days (test days will be separated by at least 1 day in between tests for each participant) |
Countries
Canada
Outcome results
None listed