Clinical trial NCT02956369: Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.
Official title: Chronic Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effect of chronic SATIOSTAT intake on total body weight
timeFrame: change from baseline to 6 weeks after SATIOSTAT intake
Secondary outcomes:
measure: Effect of chronic SATIOSTAT intake on glucose tolerance measured by oral glucose tolerance test
timeFrame: change from baseline to 6 weeks after SATIOSTAT intake
measure: Effect of chronic SATIOSTAT intake on human gut microbiota composition measured by metagenomic shotgun sequencing
timeFrame: change from baseline to 6 weeks after SATIOSTAT intake
measure: Effect of chronic SATIOSTAT intake on gut microbial-related metabolites in feces
timeFrame: change from baseline to 6 weeks after SATIOSTAT intake
measure: Effect of chronic SATIOSTAT intake on gastrointestinal symptoms assessed by questionnaire
timeFrame: change from baseline to 6 weeks after SATIOSTAT intake
measure: Effect of chronic SATIOSTAT intake on quality of life assessed by questionnaire
timeFrame: change from baseline to 6 weeks after SATIOSTAT intake
measure: Effect of chronic SATIOSTAT intake on plasma Glucagon-like Peptide (GLP-1) concentrations measured by ELISA
timeFrame: change from baseline to 6 weeks after SATIOSTAT intake
measure: Effect of chronic SATIOSTAT intake on subjective feelings of hunger and satiety measured by visual analogue scale
timeFrame: change from baseline to 6 weeks after SATIOSTAT intake
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St Claraspital
Study officials:
affiliation: St. Claraspital klinische Forschungsabteilung
name: Christoph Beglinger, MD
role: STUDY_CHAIR
References: