EN: Insulin resistance/Type 2 diabetes mellitus NL: Insuline resistentie/Type 2 diabetes mellitus
Conditions
Interventions
Volunteers will receive four different test meals on separate days (at least 1 week interval). The test meals are:
1. Pasta
2. Control bread
3. High GI bread
4. Low GI bread.
With the test meals 10 mg diet-halvarine, 2 slices lean ham and 250 mL of water will be provided. The test products will be made from wheat flour/kernels, wheat bran, water, yeast an
Sponsors
Top Institute Food and Nutrition (TIFN)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male volunteer (at least 18 y old); 2. Used to eat breakfast (solid food); 3. Not involved in intensive sportive activities more than twice a week (e.g. playing football, tennis, running, race-cycling, swimming); 4. Stable weight and no intention to lose weight until completion of the study; 5. Signed written informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. BMI 25 kg/m2; 2. Not being able to fast overnight (12 hours); 3. Diabetes mellitus; 4. Gastrointestinal disorders (including constipation); 5. Undergone digestive tract surgery (except appendectomy); 6. Stool frequency of less than 3 times a week; 7. Clinically significant inflammatory disease (possibly interfering with measurement of parameters in this study); 8. Intake of medication (from 2 weeks before screening until the end of the study, except for sporadic use of paracetamol and/or treating an AE); 9. Intake of antibiotics in the three months before the study; 10. Donation of blood within the last 3 months prior to admission to the clinic; 11. Participation to another clinical study within 90 days before enrolment; 12. Positive drug screen or alcohol breath test at D-1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main parameters of this study are postprandial plasma concentrations of glucose and insulin as well as the rate of appearance of exogenous glucose in plasma (glucose kinetics). Glucose kinetics is calculated using total plasma glucose concentration, the 13C/12C-ratio of glucose in plasma samples, and the 2H/1H-glucose ratio in plasma samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are plasma concentrations of incretins. Metabolomic analysis will be performed in plasma and urine samples. In breath samples 13CO2 will be measured. In feces samples incorporation of 13C in intestinal microbes (after Low GI bread) will be determined. Sensation of appetite and satiety (VAS) after consumption of the test meal is also considered as a secondary parameter. Other study parameters include body weight, BMI, family history of T2DM, habitual diet, smoking habits, sportive activities, the liking of the test meal (VAS) as well as feeling and extent of discomfort after consumption of the test meal. | — |
Contacts
Public ContactM.G. Priebe
University Medical Center Groningen (UMCG) Antonius Deusinglaan 1
Outcome results
None listed