An interventional study of Control and SATIOSTAT in Obesity, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Basic science
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.
1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.
This study's enrollment of 20 is below the median of 73 across 1,496 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Dietary Supplement: Control
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.
Dietary Supplement: SATIOSTAT
Control granulates (maize starch and long-chain fatty acids) with powder
Also known as: The energy content of one single bottle control is also 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.
SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder
Also known as: The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.
Effect of chronic SATIOSTAT intake on total body weight
Time frame: change from baseline to 6 weeks after SATIOSTAT intake
Effect of chronic SATIOSTAT intake on glucose tolerance measured by oral glucose tolerance test
measured with oral glucose tolerance test
Time frame: change from baseline to 6 weeks after SATIOSTAT intake
Effect of chronic SATIOSTAT intake on human gut microbiota composition measured by metagenomic shotgun sequencing
measured with metagenomic shotgun sequencing
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: change from baseline to 6 weeks after SATIOSTAT intake
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Basel, Switzerland