Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-22 @ 4:13 PM
Study NCT ID:
NCT02956369
Status:
COMPLETED
Last Update Posted:
2019-08-14
First Post:
2016-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018955', 'term': 'CD36 Antigens'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}], 'ancestors': [{'id': 'D010980', 'term': 'Platelet Membrane Glycoproteins'}, {'id': 'D008562', 'term': 'Membrane Glycoproteins'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D050612', 'term': 'Fatty Acid Transport Proteins'}, {'id': 'D026901', 'term': 'Membrane Transport Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D051122', 'term': 'Scavenger Receptors, Class B'}, {'id': 'D051116', 'term': 'Receptors, Scavenger'}, {'id': 'D011973', 'term': 'Receptors, LDL'}, {'id': 'D018110', 'term': 'Receptors, Lipoprotein'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2016-11-02', 'studyFirstSubmitQcDate': '2016-11-04', 'lastUpdatePostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of chronic SATIOSTAT intake on total body weight', 'timeFrame': 'change from baseline to 6 weeks after SATIOSTAT intake'}], 'secondaryOutcomes': [{'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', 'description': 'measured with oral glucose tolerance test'}, {'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', 'description': 'measured with metagenomic shotgun sequencing'}, {'measure': 'Effect of chronic SATIOSTAT intake on gut microbial-related metabolites in feces', 'timeFrame': 'change from baseline to 6 weeks after SATIOSTAT intake', 'description': 'Metabolomic analysis of the bacterial metabolites present in the feces by combining nuclear magnetic resonance (1H-NMR) and mass spectrometry'}, {'measure': 'Effect of chronic SATIOSTAT intake on gastrointestinal symptoms assessed by questionnaire', 'timeFrame': 'change from baseline to 6 weeks after SATIOSTAT intake', 'description': 'Assessment by use of the Gastrointestinal Symptoms Rating Scale (Svedlund et al)'}, {'measure': 'Effect of chronic SATIOSTAT intake on quality of life assessed by questionnaire', 'timeFrame': 'change from baseline to 6 weeks after SATIOSTAT intake', 'description': 'Assessment by use of the short form (SF)-36 questionnaire'}, {'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', 'description': 'measured by commercially available ELISA (enzyme-linked immunosorbent assay )-kits'}, {'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', 'description': 'measured by using visual analogue scales'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': '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.\n\nOver 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese volunteers (BMI \\> 30kg/m2)\n* Otherwise healthy\n* Informed Consent as documented by signature (Appendix Informed Consent Form)\n\nExclusion Criteria:\n\n* Food allergies, food intolerance\n* Evidence of relevant cardiovascular, pulmonary, renal, hepatic, pancreatic, gastrointestinal, metabolic, endocrinological, neurological, psychiatric or other diseases at screening\n* Chronic or clinically relevant acute infections\n* Clinically relevant abnormalities in chemical, haematological or any other laboratory parameters\n* Participation in drug trials within 2 months before start of the study\n* Neurological or psychiatric disease or drug or alcohol abuse, which would interfere with the subjects proper completion of the protocol assignment\n* 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.\n* Antibiotic therapy within the last 3 months before inclusion\n* Substance abuse, alcohol abuse\n* Inability to follow procedures due to psychological disorders, dementia or insufficient\n* Knowledge of project language (German).\n* Participation in another study with investigational drug within the 30 days preceding and during the present study.'}, 'identificationModule': {'nctId': 'NCT02956369', 'briefTitle': 'Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Chronic Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.', 'orgStudyIdInfo': {'id': 'SATIOSTAT chronic effects'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': '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.', 'interventionNames': ['Dietary Supplement: Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SATIOSTAT', 'description': '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.', 'interventionNames': ['Dietary Supplement: SATIOSTAT']}], 'interventions': [{'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['The energy content of one single bottle control is also 138kcal and contains 7.6g fat, 11.1g carbohydrates and 3.9g protein.'], 'description': 'Control granulates (maize starch and long-chain fatty acids) with powder', 'armGroupLabels': ['Control']}, {'name': 'SATIOSTAT', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['The energy content of one single bottle SATIOSTAT is 138kcal and contains 10.5g fat, 6.4g carbohydrates and 3.9g protein.'], 'description': 'SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder', 'armGroupLabels': ['SATIOSTAT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4016', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'St Claraspital', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Christoph Beglinger, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'St. Claraspital klinische Forschungsabteilung'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}