Investigation of the effects of carbohydrates on hormonal responses in healthy adults.
Conditions
Interventions
Group 1: 5 g isomaltulose (single dose, oral, dissolved in water, total volume 250 ml)
The subjects take part in a total of four study visits, separated by a wash-out phase of 14±7 days. At each visi
Sponsors
Beneo GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Subject is in good physical and mental health as established by medical history and physical examination Age: 18-50 years BMI =18.5 and =30.0 kg/m² No medications known to affect glucose tolerance (excluding oral contraceptives) — stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are acceptable Nonsmoker No changes in food habits or physical activity 6 months prior to screening and during the study Written informed consent to participate in the study Able and willing to follow the study protocol procedures.
Exclusion criteria
Exclusion criteria: A known history of diabetes mellitus or the use of antihyperglycaemic drugs or insulin to treat diabetes and related conditions A major medical or surgical event requiring hospitalization within the preceding 5 months Known fructose intolerance or malabsorption The presence of disease or drug(s) which influence digestion and absorption of nutrients The use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of the active GLP-1 concentration in the blood: GLP-1 (glucagon-like peptide 1) is measured in the plasma samples at the time points pre, 15, 30 45, 60, 90 and 120 min post. The pharmacokinetic characteristics are determined from the concentration-time curves (incremental area under the curve, iAUC). | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of the total GLP-1 concentration in the blood: GLP-1 is measured in the plasma samples at the time points pre, 15, 30 45, 60, 90 and 120 min post. The pharmacokinetic characteristics are determined from the concentration-time curves (incremental area under the curve, iAUC). Measurement of the blood glucose concentration in the blood: Blood glucose is measured in plasma samples at the time points pre, 15, 30 45, 60, 90 and 120 min post. The pharmacokinetic characteristics are determined from the concentration-time curves (incremental area under the curve, iAUC). Measurement of the insulin concentration in the blood: Insulin is measured in the plasma samples at the time points pre and 120 min post. The insulin sensitivity index is determined from the values. | — |
Countries
Germany
Outcome results
None listed