Clinical trial NCT04919850: Effect of 60-days Saccharomyces Boulardii and Superoxide Dismutase Supplementation in Obese Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Superoxide Dismutase
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* I class of obesity (BMI: 30-35 Kg/m2)

Exclusion Criteria:

* evidence of heart, kidney or liver disease
* diagnosis of major depressive disorder
* current medications for weight loss, for control of cholesterol and triglycerides
* anti-inflammatory treatments
* pregrancy of lactation
* type 1 diabetes mellitus, intestinal inflammatory bowel disease, celiac disease, chronic pancreatitis
* probiotic/prebiotic treatment in the last 4 weeks
* antibiotic use within the last 3 months

Primary outcomes:
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
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
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
measure: Change on concentration of biochemical parameters for glico-metabolic status
timeFrame: Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks
measure: Change on concentration of biochemical parameters for glico-metabolic status
timeFrame: Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks
measure: Change on concentration of biochemical parameters for glico-metabolic status
timeFrame: Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks
measure: Change on concentration of biochemical parameters for glico-metabolic status
timeFrame: Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks
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
Secondary outcomes:
measure: Change on concentration of biochemical parameters for nutritional status
timeFrame: Changes from baseline biochemical parameters for nutritional status at 8 weeks
measure: Change on concentration of biochemical parameters for hormonal status
timeFrame: Changes from baseline biochemical parameters for hormonal status at 8 weeks
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
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
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
measure: Change on concentration of biochemical parameters for safety
timeFrame: Changes from baseline biochemical parameters for safety at 8 weeks
measure: Change on concentration of biochemical parameters for safety
timeFrame: Changes from baseline biochemical parameters for safety at 8 weeks
measure: Change on rate of anthropometric measures
timeFrame: Changes from baseline anthropometric measures at 8 weeks
measure: Change on rate of anthropometric measures
timeFrame: Changes from baseline anthropometric measures at 8 weeks
measure: Change on rate of anthropometric measures
timeFrame: Changes from baseline anthropometric measures at 8 weeks
measure: Change on rate of body composition
timeFrame: Changes from baseline body composition at 8 weeks
measure: Change on rate of body composition
timeFrame: Changes from baseline body composition at 8 weeks
measure: Change on rate of body composition
timeFrame: Changes from baseline body composition at 8 weeks
measure: Change on status of mood assessment
timeFrame: Changes from baseline mood assessment at 8 weeks
measure: Change on status of assessment of food preferences
timeFrame: Changes from baseline assessment of food preferences at 8 weeks
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Azienda di Servizi alla Persona
Study officials:
References: