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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.
Over a period of 6 weeks, volunteers will ingest SATIOSTAT as meal replacement at lunch and as first course at dinner. Once before and after these 6 weeks the investigators will carry out an oral glucose challenge, measure satiation hormones and examine faeces (gut microbiota). Volunteers will fill in a food diary and a questionnaire for gastrointestinal symptoms and quality of life. The whole study will take approximately 8-10 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | 10 obese, non-diabetic candidates will serve as control-group. All assessments are carried out just as in the intervention groups. The control granulates consists of maize starch and long-chain fatty acids with powder. |
|
| SATIOSTAT | Active Comparator | 10 obese, non-diabetic candidates will ingest SATIOSTAT as meal replacement at lunch and as first course at dinner over a period of 6 weeks. The SATIOSTAT granulates consists of hydrocolloids (fibers) and long-chain fatty acids with powder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Dietary Supplement | Control granulates (maize starch and long-chain fatty acids) with powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of chronic SATIOSTAT intake on total body weight | change from baseline to 6 weeks after SATIOSTAT intake |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of chronic SATIOSTAT intake on glucose tolerance measured by oral glucose tolerance test | measured with oral glucose tolerance test | change from baseline to 6 weeks after SATIOSTAT intake |
| Effect of chronic SATIOSTAT intake on human gut microbiota composition measured by metagenomic shotgun sequencing |
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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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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D018955 | CD36 Antigens |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| ID | Term |
|---|---|
| D010980 | Platelet Membrane Glycoproteins |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| SATIOSTAT | Dietary Supplement | SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder |
|
|
measured with metagenomic shotgun sequencing |
| change from baseline to 6 weeks after SATIOSTAT intake |
| Effect of chronic SATIOSTAT intake on gut microbial-related metabolites in feces | Metabolomic analysis of the bacterial metabolites present in the feces by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry | change from baseline to 6 weeks after SATIOSTAT intake |
| Effect of chronic SATIOSTAT intake on gastrointestinal symptoms assessed by questionnaire | Assessment by use of the Gastrointestinal Symptoms Rating Scale (Svedlund et al) | change from baseline to 6 weeks after SATIOSTAT intake |
| Effect of chronic SATIOSTAT intake on quality of life assessed by questionnaire | Assessment by use of the short form (SF)-36 questionnaire | change from baseline to 6 weeks after SATIOSTAT intake |
| Effect of chronic SATIOSTAT intake on plasma Glucagon-like Peptide (GLP-1) concentrations measured by ELISA | measured by commercially available ELISA (enzyme-linked immunosorbent assay )-kits | change from baseline to 6 weeks after SATIOSTAT intake |
| Effect of chronic SATIOSTAT intake on subjective feelings of hunger and satiety measured by visual analogue scale | measured by using visual analogue scales | change from baseline to 6 weeks after SATIOSTAT intake |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |