Acute Effects of SATIOSTAT Ingestion on Satiation Hormones, Gastric Emptying, Subjective Feelings of Appetite and Energy Intake

Study Overview
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Brief Summary
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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.

Official Title
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Acute Effects of SATIOSTAT Ingestion on Satiation Hormones, Gastric Emptying, Subjective Feelings of Appetite and Energy Intake

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Control treatment + oral glucose
* Dietary Supplement: SATIOSTAT treatment + oral glucose
* Dietary Supplement: Control treatment + meal intake
* Dietary Supplement: SATIOSTAT treatment + meal intake


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control treatment + oral glucose<br>Control treatment as preload and then an oral glucose load of 75g enriched with C13 sodium acetate (for determination of gastric emptying rates) | Dietary Supplement: Control treatment + oral glucose<br>* Control granulates (maize starch and long-chain fatty acids) with powder; 75g oral glucose load<br>* Other names: The energy content of one single bottle control is 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.;|
| Active Comparator: SATIOSTAT treatment + oral glucose<br>SATIOSTAT treatment as preload and then an oral glucose load of 75g enriched with C13 sodium acetate (for determination of gastric emptying rates) | Dietary Supplement: SATIOSTAT treatment + oral glucose<br>* SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; 75g oral glucose load<br>* Other names: The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.;|
| Placebo Comparator: Control treatment + meal intake<br>Control treatment as preload followed by a test meal | Dietary Supplement: Control treatment + meal intake<br>* 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)<br>* Other names: The energy content of one single bottle control is 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.;|
| Active Comparator: SATIOSTAT treatment + meal intake<br>SATIOSTAT treatment as preload followed by a test meal | Dietary Supplement: SATIOSTAT treatment + meal intake<br>* 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)<br>* Other names: The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |