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 series 1
dextrose (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENTsecond reference product seies 1
dextrose (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENTthird reference product series 1
dextrose (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENTfirst concept product series 1
Standard tube feed (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENTsecond concept product series 1
Tube feed with added fibers (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENTthird concept product series 1
Tube feed with extra energy (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENT4th concept product seris 1
Tube feed with extra energy and added fibers (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENT5th concept product series 1
Plant based oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates
DIETARY_SUPPLEMENT6th concept product series 1
Oral nutritional supplement for disease related malnutrition in patients with malabsorption and/or maldigestion (containing 25 grams of carbohydrates
DIETARY_SUPPLEMENT1st reference product series 2
dextrose (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENT2nd reference product series 2
dextrose (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENT3rd reference product series 2
dextrose (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENT1st concept product series 2
High energy plant based tube feed (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENT2nd concept product series 2
High energy plant based tube feed with added fibers (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENT3rd concept product series 2
High protein tube feed (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENT4th concept product series 2
High protein, high energy tube feed based on peptides (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENT5th concept product series 2
Oral nutritional supplement for disease related malnutrition in patients with muscle loss (containing 25 grams of carbohydrates)
DIETARY_SUPPLEMENT6th concept product series 2
Oral nutritional supplement for disease related malnutrition (containing 25 grams of carbohydrates)
Sponsors
Nutricia Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
12 products will be tested (2 x 6 products + each 3 contls) that means 18 ärmsin total
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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The glycemic index of nutritional products | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 1. The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references | 6 months |
| 2. The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references | 6 months |
Countries
Canada
Outcome results
None listed