ObesityNCT02956356
Acute Effects of SATIOSTAT Ingestion on Satiation Hormones, Gastric Emptying, Subjective Feelings of Appetite and Energy Intake
A study testing SATIOSTAT treatment + oral glucose and SATIOSTAT treatment + meal intake in people with Obesity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- SATIOSTAT treatment + oral glucose and SATIOSTAT treatment + meal intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Obese volunteers (BMI > 30kg/m2)
- Otherwise healthy
- Informed Consent as documented by signature (Appendix Informed Consent Form)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obesity
- Being tested
- Control treatment + oral glucose, SATIOSTAT treatment + oral glucose, Control treatment + meal intake, SATIOSTAT treatment + meal intake
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control treatment + oral glucoseDietary supplement
Also called The energy content of one single bottle control is 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.
Control granulates (maize starch and long-chain fatty acids) with powder; 75g oral glucose load
SATIOSTAT treatment + oral glucoseDietary supplement
Also called The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.
SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; 75g oral glucose load
Control treatment + meal intakeDietary supplement
Also called The energy content of one single bottle control is 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.
Control granulates (maize starch and long-chain fatty acids) with powder; test meal (ham sandwiches: 50g bread, 10g butter, 29g ham (pork); 247 kcal/sandwich) and tap water)
SATIOSTAT treatment + meal intakeDietary supplement
Also called The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.
SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; test meal (ham sandwiches: 50g bread, 10g butter, 29g ham (pork); 247 kcal/sandwich) and tap water)
| Study group | Role | What they receive |
|---|---|---|
| Control treatment + oral glucose | Placebo comparator | Control treatment as preload and then an oral glucose load of 75g enriched with C13 sodium acetate (for determination of gastric emptying rates) Receives: Dietary Supplement: Control treatment + oral glucose |
| SATIOSTAT treatment + oral glucose | Active comparator | SATIOSTAT treatment as preload and then an oral glucose load of 75g enriched with C13 sodium acetate (for determination of gastric emptying rates) Receives: Dietary Supplement: SATIOSTAT treatment + oral glucose |
| Control treatment + meal intake | Placebo comparator | Control treatment as preload followed by a test meal Receives: Dietary Supplement: Control treatment + meal intake |
| SATIOSTAT treatment + meal intake | Active comparator | SATIOSTAT treatment as preload followed by a test meal Receives: Dietary Supplement: SATIOSTAT treatment + meal intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute effects of SATIOSTAT on gastrointestinal (GI) peptide release measured by ELISA
measured by commercially available ELISA (enzyme-linked immunosorbent assay )-kits
Measured: changes from baseline to three hours after treatment
Secondary outcomes (4)
Acute effects of SATIOSTAT on glucose tolerance measured by oral glucose tolerance test
measured with oral glucose tolerance test
Measured: changes from baseline to three hours after treatment
Acute effects of SATIOSTAT on gastric emptying measured by 13C-sodium-acetate breath test
measured by 13C-sodium-acetate breath test
Measured: changes from baseline to four hours after treatment
Acute effects of SATIOSTAT on subjective feelings of hunger and satiety measured by visual analogue scales
measured by visual analogue scales
Measured: changes from baseline to three hours after treatment
Acute effects of SATIOSTAT on subsequent calorie intake measured by calorie intake from a test meal
calorie intake from a test meal will be assessed
Measured: changes from baseline to two hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Beglinger, MD, Study chair, St. Claraspital klinische Forschungsabteilung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956356
- Sponsor's protocol ID
- SATIOSTAT acute effects
- Status last verified
- Aug 2018
- First submitted
- 2 Nov 2016
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of SATIOSTAT Ingestion on Satiation Hormones, Gastric Emptying, Subjective Feelings of Appetite and Energy Intake
- ClinicalTrials.gov ID
- NCT02956356
- Acronym / sponsor ID
- SATIOSTAT acute effects
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control treatment + oral glucose | Placebo comparator | Dietary Supplement: Control treatment + oral glucoseControl treatment as preload and then an oral glucose load of 75g enriched with C13 sodium acetate (for determination of gastric emptying rates) |
| SATIOSTAT treatment + oral glucose | Active comparator | Dietary Supplement: SATIOSTAT treatment + oral glucoseSATIOSTAT treatment as preload and then an oral glucose load of 75g enriched with C13 sodium acetate (for determination of gastric emptying rates) |
| Control treatment + meal intake | Placebo comparator | Dietary Supplement: Control treatment + meal intakeControl treatment as preload followed by a test meal |
| SATIOSTAT treatment + meal intake | Active comparator | Dietary Supplement: SATIOSTAT treatment + meal intakeSATIOSTAT treatment as preload followed by a test meal |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Obese volunteers (BMI > 30kg/m2)
- Otherwise healthy
- Informed Consent as documented by signature (Appendix Informed Consent Form)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control treatment + oral glucoseAlso: The energy content of one single bottle control is 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.Control granulates (maize starch and long-chain fatty acids) with powder; 75g oral glucose load | Dietary supplement | Control treatment + oral glucose |
| SATIOSTAT treatment + oral glucoseAlso: The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; 75g oral glucose load | Dietary supplement | SATIOSTAT treatment + oral glucose |
| Control treatment + meal intakeAlso: The energy content of one single bottle control is 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.Control granulates (maize starch and long-chain fatty acids) with powder; test meal (ham sandwiches: 50g bread, 10g butter, 29g ham (pork); 247 kcal/sandwich) and tap water) | Dietary supplement | Control treatment + meal intake |
| SATIOSTAT treatment + meal intakeAlso: The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; test meal (ham sandwiches: 50g bread, 10g butter, 29g ham (pork); 247 kcal/sandwich) and tap water) | Dietary supplement | SATIOSTAT treatment + meal intake |
Primary outcome
Acute effects of SATIOSTAT on gastrointestinal (GI) peptide release measured by ELISA
Time frame: changes from baseline to three hours after treatment
measured by commercially available ELISA (enzyme-linked immunosorbent assay )-kits
4 secondary outcomes
Acute effects of SATIOSTAT on glucose tolerance measured by oral glucose tolerance test
Time frame: changes from baseline to three hours after treatment
Acute effects of SATIOSTAT on gastric emptying measured by 13C-sodium-acetate breath test
Time frame: changes from baseline to four hours after treatment
Acute effects of SATIOSTAT on subjective feelings of hunger and satiety measured by visual analogue scales
Time frame: changes from baseline to three hours after treatment
Acute effects of SATIOSTAT on subsequent calorie intake measured by calorie intake from a test meal
Time frame: changes from baseline to two hours after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Beglinger, MD study chair
St. Claraspital klinische Forschungsabteilung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SATIOSTAT treatment + oral glucose and SATIOSTAT treatment + meal intake in people with Obesity, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute effects of SATIOSTAT on gastrointestinal (GI) peptide release measured by ELISA (time frame: changes from baseline to three hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.