ObesityNCT02956369
Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.
A study testing SATIOSTAT 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Oct 2017to 6 May 2019
- 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
Official title: Chronic Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.
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.
- Conditions
- Obesity
- Being tested
- Control, SATIOSTAT
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDietary supplement
Also called The energy content of one single bottle control is also 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.
Control granulates (maize starch and long-chain fatty acids) with powder
SATIOSTATDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 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. Receives: Dietary Supplement: Control |
| SATIOSTAT | Active comparator | 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. Receives: Dietary Supplement: SATIOSTAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of chronic SATIOSTAT intake on total body weight
Measured: change from baseline to 6 weeks after SATIOSTAT intake
Secondary outcomes (7)
Effect of chronic SATIOSTAT intake on glucose tolerance measured by oral glucose tolerance test
measured with oral glucose tolerance test
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: change from baseline to 6 weeks after SATIOSTAT intake
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 start16 Oct 2017
- Primary completion6 May 2019
- Study completion6 May 2019
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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
- NCT02956369
- Sponsor's protocol ID
- SATIOSTAT chronic effects
- Status last verified
- Aug 2019
- First submitted
- 2 Nov 2016
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.
- ClinicalTrials.gov ID
- NCT02956369
- Acronym / sponsor ID
- SATIOSTAT chronic effects
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 6 May 2019 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: Control10 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. |
| SATIOSTAT | Active comparator | Dietary Supplement: SATIOSTAT10 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. |
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 |
|---|---|---|
| ControlAlso: The energy content of one single bottle control is also 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.Control granulates (maize starch and long-chain fatty acids) with powder | Dietary supplement | Control |
| SATIOSTATAlso: 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 | Dietary supplement | SATIOSTAT |
Primary outcome
Effect of chronic SATIOSTAT intake on total body weight
Time frame: change from baseline to 6 weeks after SATIOSTAT intake
7 secondary outcomes
Effect of chronic SATIOSTAT intake on glucose tolerance measured by 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
Time frame: change from baseline to 6 weeks after SATIOSTAT intake
Effect of chronic SATIOSTAT intake on gut microbial-related metabolites in feces
Time frame: change from baseline to 6 weeks after SATIOSTAT intake
Effect of chronic SATIOSTAT intake on gastrointestinal symptoms assessed by questionnaire
Time frame: change from baseline to 6 weeks after SATIOSTAT intake
Effect of chronic SATIOSTAT intake on quality of life assessed by 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
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
Time frame: change from baseline to 6 weeks after SATIOSTAT intake
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 14 Aug 2019.
- 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 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 14 Aug 2019. 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?
Effect of chronic SATIOSTAT intake on total body weight (time frame: change from baseline to 6 weeks after SATIOSTAT intake). 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 14 Aug 2019.