Obesity
Conditions
Brief summary
SATIOSTAT is a composition comprising a specific dietary fibre component (a mixture of hydrocolloids with excellent safety profiles and a long history of use in humans) and a lipid component (long-chain fatty acids). The goal of this combination is to achieve long-acting delivery of long-chain fatty acids to the intestinal lining, triggering the sustained release of satiety-signals from intestinal cells, and consequently reducing appetite and lowering food intake in humans. Effects of acute ingestion of SATIOSTAT vs. a control will be examined. On a first and second study day, volunteers receive a preload of either SATIOSTAT or a control and then an oral glucose load of 75g enriched with C13 sodium acetate. Gastric emptying will be measured by means of a breath test, and insulin, glucose and satiation hormones will be assessed. On the third and fourth study day, volunteers receive a preload of either SATIOSTAT or a control and are then presented a test meal. Total calorie intake is measured as well as subjective feelings of satiation. In addition satiation hormones are measured.
Interventions
DIETARY_SUPPLEMENTControl treatment + oral glucose
Control granulates (maize starch and long-chain fatty acids) with powder; 75g oral glucose load
DIETARY_SUPPLEMENTSATIOSTAT treatment + oral glucose
SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; 75g oral glucose load
DIETARY_SUPPLEMENTControl treatment + meal intake
Control granulates (maize starch and long-chain fatty acids) with powder; test meal (ham sandwiches: 50g bread, 10g butter, 29g ham (pork); 247 kcal/sandwich) and tap water)
DIETARY_SUPPLEMENTSATIOSTAT treatment + meal intake
SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; test meal (ham sandwiches: 50g bread, 10g butter, 29g ham (pork); 247 kcal/sandwich) and tap water)
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Obese volunteers (BMI \> 30kg/m2) * Otherwise healthy * Informed Consent as documented by signature (Appendix Informed Consent Form)
Exclusion criteria
* Food allergies, food intolerance * Evidence of relevant cardiovascular, pulmonary, renal, hepatic, pancreatic, gastrointestinal, metabolic, endocrinological, neurological, psychiatric or other diseases at screening * Chronic or clinically relevant acute infections * Clinically relevant abnormalities in chemical, haematological or any other laboratory parameters * Participation in drug trials within 2 months before start of the study * Neurological or psychiatric disease or drug or alcohol abuse, which would interfere with the subjects proper completion of the protocol assignment * Pregnancy: although no contraindication pregnancy might influence metabolic state. Women who are pregnant or have the intention to become pregnant during the course of the study are excluded. In female participants of childbearing age not using safe contraception (oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) a urine pregnancy test is carried out upon screening. * Antibiotic therapy within the last 3 months before inclusion * Substance abuse, alcohol abuse * Inability to follow procedures due to psychological disorders, dementia or insufficient * Knowledge of project language (German). * Participation in another study with investigational drug within the 30 days preceding and during the present study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute effects of SATIOSTAT on gastrointestinal (GI) peptide release measured by ELISA | changes from baseline to three hours after treatment | measured by commercially available ELISA (enzyme-linked immunosorbent assay )-kits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute effects of SATIOSTAT on glucose tolerance measured by oral glucose tolerance test | changes from baseline to three hours after treatment | measured with oral glucose tolerance test |
| Acute effects of SATIOSTAT on gastric emptying measured by 13C-sodium-acetate breath test | changes from baseline to four hours after treatment | measured by 13C-sodium-acetate breath test |
| Acute effects of SATIOSTAT on subjective feelings of hunger and satiety measured by visual analogue scales | changes from baseline to three hours after treatment | measured by visual analogue scales |
| Acute effects of SATIOSTAT on subsequent calorie intake measured by calorie intake from a test meal | changes from baseline to two hours after treatment | calorie intake from a test meal will be assessed |
Countries
Switzerland
Outcome results
None listed