CompletedNot Applicable

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

Switzerland15 participantsStarted 2016-10

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 durin…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acute effects of SATIOSTAT on gastrointestinal (GI) peptide release measured by ELISA

Timeframe: changes from baseline to three hours after treatment

Trial details

NCT IDNCT02956356

SponsorUniversity Hospital, Basel, Switzerland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-02

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