Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-28 @ 5:06 AM
Study NCT ID:
NCT04919850
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2021-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of 60-days Saccharomyces Boulardii and Superoxide Dismutase Supplementation in Obese Adults
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': 'D013482', 'term': 'Superoxide Dismutase'}], 'ancestors': [{'id': 'D010088', 'term': 'Oxidoreductases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-03', 'studyFirstSubmitDate': '2021-05-27', 'studyFirstSubmitQcDate': '2021-06-03', 'lastUpdatePostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change on concentration of biochemical parameters for hunger sensation and hormonal status', 'timeFrame': 'Changes from baseline biochemical parameters for hunger sensation and hormonal status at 8 weeks', 'description': 'Ghrelin (pg/mL), Adiponectin (pg/ml), Peptide YY (pg/ml)'}, {'measure': 'Change on concentration of biochemical parameters for hunger sensation and hormonal status', 'timeFrame': 'Changes from baseline biochemical parameters for hunger sensation and hormonal status at 8 weeks', 'description': 'Leptin (ng/cL)'}, {'measure': 'Change on concentration of biochemical parameters for hunger sensation and hormonal status', 'timeFrame': 'Changes from baseline biochemical parameters for hunger sensation and hormonal status at 8 weeks', 'description': 'glucagon-like peptide - 1 (pmol/L)'}, {'measure': 'Change on concentration of biochemical parameters for glico-metabolic status', 'timeFrame': 'Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks', 'description': 'Total cholesterol (mg/dL), Low Density Lipoprotein cholesterol (mg/dL), HDL cholesterol (mg/dL), Triglycerides (mg/dL), Apolipoprotein A (mg/dL), Apolipoprotein B (mg/dL), Glycemia (mg/dL), Uric acid (mg/dL)'}, {'measure': 'Change on concentration of biochemical parameters for glico-metabolic status', 'timeFrame': 'Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks', 'description': 'Insulin (mcU/mL)'}, {'measure': 'Change on concentration of biochemical parameters for glico-metabolic status', 'timeFrame': 'Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks', 'description': 'Total Proteins (g/dL), Albumin (g/dL)'}, {'measure': 'Change on concentration of biochemical parameters for glico-metabolic status', 'timeFrame': 'Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks', 'description': 'HOMA index (pt)'}, {'measure': 'Change on state of hunger, fullness, desire to eat, satiety and prospective food consumption', 'timeFrame': 'Changes from baseline state of hunger, fullness, desire to eat, satiety and prospective food consumption at 8 weeks', 'description': 'Eating motivation Visual Analogue Scale (pt): a scale from 0 to 10 points. The scale of hunger (question: "how hungry are you?") ranged from the answer "not at all" to "as hungry as I have ever felt"; the scale of fullness (question: "how full are you?") ranged from the answer "not at all" to "as full as I ever felt"; the scale of satiety (question: "how satiated are you?") ranged from "not at all" to "extremely"; the scale of desire (question: "how strong is your desire to eat?") ranged from "very weak" to "very strong"; the scale of prospective consumption (question: "how much do you think you could (or would want to) eat right now) ranged from "nothing at all" to "a very large amount"'}], 'secondaryOutcomes': [{'measure': 'Change on concentration of biochemical parameters for nutritional status', 'timeFrame': 'Changes from baseline biochemical parameters for nutritional status at 8 weeks', 'description': 'Iron (µg/dL)'}, {'measure': 'Change on concentration of biochemical parameters for hormonal status', 'timeFrame': 'Changes from baseline biochemical parameters for hormonal status at 8 weeks', 'description': 'Thyroid Stimulating Hormone (µU/dL)'}, {'measure': 'Change on concentration of biochemical parameters for inflammation and cardiovascular risk', 'timeFrame': 'Changes from baseline biochemical parameters for inflammation and cardiovascular risk at 8 weeks', 'description': 'C-Reactive Protein (mg/dL)'}, {'measure': 'Change on concentration of biochemical parameters for inflammation and cardiovascular risk', 'timeFrame': 'Changes from baseline biochemical parameters for inflammation and cardiovascular risk at 8 weeks', 'description': 'Tumor Necrosis Factor-α (pg/mL), Inter Leukin-1β (pg/mL), Inter Leukin-6 (pg/mL)'}, {'measure': 'Change on concentration of biochemical parameters for inflammation and cardiovascular risk', 'timeFrame': 'Changes from baseline biochemical parameters for inflammation and cardiovascular risk at 8 weeks', 'description': 'Trimethylamine (µM), Trimethylamine-N-oxide (µM)'}, {'measure': 'Change on concentration of biochemical parameters for safety', 'timeFrame': 'Changes from baseline biochemical parameters for safety at 8 weeks', 'description': 'Aspartate amino transferase (U/L), Alanine amino transferase (U/L), Gamma Glutamyl Transferase (U/L)'}, {'measure': 'Change on concentration of biochemical parameters for safety', 'timeFrame': 'Changes from baseline biochemical parameters for safety at 8 weeks', 'description': 'Creatinine (mg/dl)'}, {'measure': 'Change on rate of anthropometric measures', 'timeFrame': 'Changes from baseline anthropometric measures at 8 weeks', 'description': 'Height (cm), waist circumference (cm)'}, {'measure': 'Change on rate of anthropometric measures', 'timeFrame': 'Changes from baseline anthropometric measures at 8 weeks', 'description': 'Weight (Kg)'}, {'measure': 'Change on rate of anthropometric measures', 'timeFrame': 'Changes from baseline anthropometric measures at 8 weeks', 'description': 'Body mass index (kg/m2)'}, {'measure': 'Change on rate of body composition', 'timeFrame': 'Changes from baseline body composition at 8 weeks', 'description': 'Free Fat Mass (kg), Fat Mass (kg)'}, {'measure': 'Change on rate of body composition', 'timeFrame': 'Changes from baseline body composition at 8 weeks', 'description': 'Android fat (%), Gynoid fat (%)'}, {'measure': 'Change on rate of body composition', 'timeFrame': 'Changes from baseline body composition at 8 weeks', 'description': 'Visceral Adipose Tissue (g)'}, {'measure': 'Change on status of mood assessment', 'timeFrame': 'Changes from baseline mood assessment at 8 weeks', 'description': 'Beck questionnaire (pt). The questionnaire is divided into 21 items which have a score from 0 to 3. A total score \\> 17 indicates borderline depression; \\> 21 moderate depression; \\> 31 severe depression; \\> 40 extreme depression.'}, {'measure': 'Change on status of assessment of food preferences', 'timeFrame': 'Changes from baseline assessment of food preferences at 8 weeks', 'description': 'Food Frequency Questionnaire (pt). Participants must indicate the consumption of 18 common food items, choosing one between "yes" or "no, never". Participants were also asked to estimate their usual rate of consumption, choosing from seven categories of frequency, ranging from \'\'never\'\' or \'\'less than once a week\'\' to \'\'seven times per week". The only exception was constituted by the item "coffee consumption", which is reported as "cups/day".'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Superoxide Dismutase']}, 'descriptionModule': {'briefSummary': 'In animals it has been demonstrated that Saccharomyces boulardii decrease low-grade inflammation and fat mass; also Superoxide Dismutase (SOD) decrease low-grade inflammation. Therefore, the aim of this double-blind, placebo-controlled clinical trial was to assess the effect of a 60-days S. boulardii and SOD supplementation on circulating markers of inflammation, body composition, hunger sensation, pro/antioxidant ratio, hormonal, lipid profile, glucose, insulin and HOMA-IR, in obese adults (BMI 30-35 kg/m2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* I class of obesity (BMI: 30-35 Kg/m2)\n\nExclusion Criteria:\n\n* evidence of heart, kidney or liver disease\n* diagnosis of major depressive disorder\n* current medications for weight loss, for control of cholesterol and triglycerides\n* anti-inflammatory treatments\n* pregrancy of lactation\n* type 1 diabetes mellitus, intestinal inflammatory bowel disease, celiac disease, chronic pancreatitis\n* probiotic/prebiotic treatment in the last 4 weeks\n* antibiotic use within the last 3 months'}, 'identificationModule': {'nctId': 'NCT04919850', 'briefTitle': 'Effect of 60-days Saccharomyces Boulardii and Superoxide Dismutase Supplementation in Obese Adults', 'organization': {'class': 'OTHER', 'fullName': 'Azienda di Servizi alla Persona di Pavia'}, 'officialTitle': 'Effect of 60-days Saccharomyces Boulardii and Superoxide Dismutase Supplementation on Body Composition, Hunger Sensation, Pro/Antioxidant Ratio, Inflammation and Hormonal Lipo-metabolic Biomarkers in Obese Adults: a Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '1209/151217'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group', 'description': 'A complex of 250 mg of Saccharomyces boulardii and 500 IU SOD to be assumed twice/day for 8 weeks at mealtimes', 'interventionNames': ['Dietary Supplement: Saccharomyces boulardii and SOD']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'A placebo consisting of capsules containing the same excipients except the active compounds, and the same coating', 'interventionNames': ['Combination Product: Placebo']}], 'interventions': [{'name': 'Saccharomyces boulardii and SOD', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A complex of 250 mg of Saccharomyces boulardii and 500 IU SOD to be assumed twice/day for 8 weeks at mealtimes', 'armGroupLabels': ['Intervention group']}, {'name': 'Placebo', 'type': 'COMBINATION_PRODUCT', 'description': 'A placebo consisting of capsules containing the same excipients except the active compounds, and the same coating', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Azienda di Servizi alla Persona', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda di Servizi alla Persona di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mariangela Rondanelli', 'investigatorAffiliation': 'Azienda di Servizi alla Persona di Pavia'}}}}