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_SUPPLEMENTFirst Reference product
dextrose (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENTSecond reference product
dextrose (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENTThird reference product
dextrose (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENTFirst Concept product
Plant-Based Oat Beverage with Sugar 1 (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENTSecond Concept product
Plant-Based Oat Beverage with Sugar 2 (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENTThird Concept product
Plant-Based Oat Beverage with Sugar 3 (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENTFourth Concept product
Plant-Based Oat Beverage with Sugar 4 (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENTFifth Concept product
Plant-Based Oat Beverage No Sugar 1(containing 25 grams of carbohydrates
DIETARY_SUPPLEMENTSixth Concept product
Plant-Based Oat Beverage No Sugar 2 (containing 25 grams of carbohydrates
DIETARY_SUPPLEMENTSeventh Concept product
High calorie, high protein oral powder nutritional supplement. (containing 25 grams of carbohydrates
Sponsors
INQUIS Clinical Research
Nutricia Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
10 products will be tested (7 test products and 3 controls)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The glycemic index of nutritional products | from enrollment to the end of treatment at about 9 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 2. The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references | from enrollment to the end of treatment at about 9 weeks |
| 1. The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references | from enrollment to the end of treatment at about 9 weeks |
Countries
Canada
Outcome results
None listed