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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control treatment + oral glucose | Placebo Comparator | Control treatment as preload and then an oral glucose load of 75g enriched with C13 sodium acetate (for determination of gastric emptying rates) |
|
| SATIOSTAT treatment + oral glucose | Active Comparator | SATIOSTAT treatment as preload and then an oral glucose load of 75g enriched with C13 sodium acetate (for determination of gastric emptying rates) |
|
| Control treatment + meal intake | Placebo Comparator | Control treatment as preload followed by a test meal |
|
| SATIOSTAT treatment + meal intake | Active Comparator | SATIOSTAT treatment as preload followed by a test meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control treatment + oral glucose | Dietary Supplement | Control granulates (maize starch and long-chain fatty acids) with powder; 75g oral glucose load |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute effects of SATIOSTAT on gastrointestinal (GI) peptide release measured by ELISA | measured by commercially available ELISA (enzyme-linked immunosorbent assay )-kits | changes from baseline to three hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Acute effects of SATIOSTAT on glucose tolerance measured by oral glucose tolerance test | measured with oral glucose tolerance test | changes from baseline to three hours after treatment |
| Acute effects of SATIOSTAT on gastric emptying measured by 13C-sodium-acetate breath test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Beglinger, MD | St. Claraspital klinische Forschungsabteilung | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Claraspital | Basel | 4016 | Switzerland |
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|
| SATIOSTAT treatment + oral glucose | Dietary Supplement | SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; 75g oral glucose load |
|
|
| Control treatment + meal intake | Dietary Supplement | 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) |
|
|
| SATIOSTAT treatment + meal intake | Dietary Supplement | 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) |
|
|
measured by 13C-sodium-acetate breath test |
| changes from baseline to four hours after treatment |
| Acute effects of SATIOSTAT on subjective feelings of hunger and satiety measured by visual analogue scales | measured by visual analogue scales | changes from baseline to three hours after treatment |
| Acute effects of SATIOSTAT on subsequent calorie intake measured by calorie intake from a test meal | calorie intake from a test meal will be assessed | changes from baseline to two hours after treatment |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| D018955 | CD36 Antigens |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D010980 | Platelet Membrane Glycoproteins |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D050612 | Fatty Acid Transport Proteins |
| D026901 | Membrane Transport Proteins |
| D002352 | Carrier Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D011956 | Receptors, Cell Surface |
| D011971 | Receptors, Immunologic |
| D051122 | Scavenger Receptors, Class B |
| D051116 | Receptors, Scavenger |
| D011973 | Receptors, LDL |
| D018110 | Receptors, Lipoprotein |
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