Postprandial glycaemia Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated consent prior to any study procedures 2. Men or women aged 18 to 70 years 3. Subject's laboratory evaluation at the screening visit must be within normal limits (with the exception of abnormalities considered as clinically insignificant in the opinion of the study physician)
Exclusion criteria
Exclusion criteria: 1. Subject with type 1 diabetes 2. Subject with type 2 diabetes 3. Subject requiring antiglycemic medication 4. Subject with allergy or sensitivity to an ingredient of the test product 5. Subject with active hepatic, kidney or thyroid disease or disorder except the subjects on thyroid replacement therapy 6. Female subject who is pregnant or lactating 7. Subject with: haemoglobin 7.0 mmol/l, plasma gamma-glutamyl transferase > 2 x upper limit of normal or plasma creatinine > 2 x upper limit of normal at the screening visit. 8. Subject with body mass index > 30 9. Subject who have had myocardial infarction within 6 months prior to screening 10. Subject with unstable angina pectoris 11. Subject who have history of temporal ischemic attack or stroke within six months prior to screening 12. Subject with malignancy within 5 years prior screening (except treated cutaneous basal cell or squamous cell cancer)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma glucose concentrations analysed from fingertip capillary and venous blood samples taken within 20 min before the ingestion of meal and at 15, 30, 45, 60, 90 and 120 min after starting the ingestion of meal. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum insulin concentrations analysed from venous blood samples taken within 20 min before the ingestion of meal and at 15, 30, 45, 60, 90 and 120 min after starting the ingestion of meal 2. Optionally, the following concentrations may be measured at the same time points: 2.1. Plasma cholecystokinin (CCK) 2.2. Glucose-dependent insulinotropic polypeptide (GIP) 2.3. Glugacon-like peptide 1 (GLP-1) 2.4. Peptide YY (PYY) 3. Body weight measured with calibrated digital scale at every study visit after 10-12 h overnight fasting | — |
Countries
Finland