not applicable
Conditions
Interventions
Participants will receive a single bolus of study product (50g carbohydrate
equivalent) together with paracetamol (1 gram) at the start of each test day.
Sponsors
Nutricia Research
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Healthy individuals, 18 up to and including 50 years of age. 2. Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial. 3. Willing to avoid the consumption of alcohol, unusual food intake, unusual physical activity 24h prior to each study visit. 4. Willing to come to the study visit in the morning after an overnight fast of minimum 10 hours and maximum 14 hours (with water only).
Exclusion criteria
Exclusion criteria: 1. Abnormal blood glucose levels at screening (not fasted) in the opinion of the investigator. 2. Known history of gastrointestinal disease (e.g., diverticulitis, Crohn*s disease, coeliac disease etc.), 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 Principal Investigator either: 1) make participation dangerous to the subject (e.g. anaemia) 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 Principal Investigator either: 1) make participation dangerous to the subject or to others, or 2) affect the results. 4. Use of medications known to influence gastric emptying (including but not limited to anticholinergics, nicotine, narcotic analgesics, ganglion blocking drugs, antacids and metoclopramide). 5. Use of anti-clotting medications. 6. Current tobacco smokers or smokers that quite smoking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter in this study is the rate of decline in glucose (mmol/hour) after reaching peak glucose levels (Cmax) until reaching baseline (t = -5) blood glucose levels or, in case baseline blood glucose levels are not reached, the lowest observed blood glucose level. | — |
Secondary
| Measure | Time frame |
|---|---|
| • incremental Area Under the Curve (iAUC) for: o glucose (mmol/L/hrs) o insulin (pmol/L/hrs) o paracetamol (mg/L/hrs) • incremental peak levels (iCmax) of: o glucose (mmol/L) o insulin (pmol/L) o paracetamol (mg/L) • time to peak levels (Tmax) of: o glucose (min) o insulin (min) o paracetamol (min) | — |
Countries
Netherlands
Outcome results
None listed