Clinical trial NCT02956356: Acute Effects of SATIOSTAT Ingestion on Satiation Hormones, Gastric Emptying, Subjective Feelings of Appetite and Energy Intake
Official title: Acute Effects of SATIOSTAT Ingestion on Satiation Hormones, Gastric Emptying, Subjective Feelings of Appetite and Energy Intake
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: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.

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.


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: Acute effects of SATIOSTAT on gastrointestinal (GI) peptide release measured by ELISA
timeFrame: changes from baseline to three hours after treatment
Secondary outcomes:
measure: Acute effects of SATIOSTAT on glucose tolerance measured by oral glucose tolerance test
timeFrame: changes from baseline to three hours after treatment
measure: Acute effects of SATIOSTAT on gastric emptying measured by 13C-sodium-acetate breath test
timeFrame: changes from baseline to four hours after treatment
measure: Acute effects of SATIOSTAT on subjective feelings of hunger and satiety measured by visual analogue scales
timeFrame: changes from baseline to three hours after treatment
measure: Acute effects of SATIOSTAT on subsequent calorie intake measured by calorie intake from a test meal
timeFrame: changes from baseline to two hours after treatment
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: