Effect of 60-days Saccharomyces Boulardii and Superoxide Dismutase Supplementation in Obese Adults

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Obesity, Superoxide Dismutase

Intervention / Treatment
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* Dietary Supplement: Saccharomyces boulardii and SOD
* Combination Product: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>A complex of 250 mg of Saccharomyces boulardii and 500 IU SOD to be assumed twice/day for 8 weeks at mealtimes | Dietary Supplement: Saccharomyces boulardii and SOD<br>* A complex of 250 mg of Saccharomyces boulardii and 500 IU SOD to be assumed twice/day for 8 weeks at mealtimes<br>|
| Placebo Comparator: Placebo group<br>A placebo consisting of capsules containing the same excipients except the active compounds, and the same coating | Combination Product: Placebo<br>* A placebo consisting of capsules containing the same excipients except the active compounds, and the same coating<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on concentration of biochemical parameters for hunger sensation and hormonal status | Ghrelin (pg/mL), Adiponectin (pg/ml), Peptide YY (pg/ml) | Changes from baseline biochemical parameters for hunger sensation and hormonal status at 8 weeks | 
| Change on concentration of biochemical parameters for hunger sensation and hormonal status | Leptin (ng/cL) | Changes from baseline biochemical parameters for hunger sensation and hormonal status at 8 weeks | 
| Change on concentration of biochemical parameters for hunger sensation and hormonal status | glucagon-like peptide - 1 (pmol/L) | Changes from baseline biochemical parameters for hunger sensation and hormonal status at 8 weeks | 
| Change on concentration of biochemical parameters for glico-metabolic status | 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) | Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks | 
| Change on concentration of biochemical parameters for glico-metabolic status | Insulin (mcU/mL) | Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks | 
| Change on concentration of biochemical parameters for glico-metabolic status | Total Proteins (g/dL), Albumin (g/dL) | Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks | 
| Change on concentration of biochemical parameters for glico-metabolic status | HOMA index (pt) | Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks | 
| Change on state of hunger, fullness, desire to eat, satiety and prospective food consumption | 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 | Changes from baseline state of hunger, fullness, desire to eat, satiety and prospective food consumption at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on concentration of biochemical parameters for nutritional status | Iron (µg/dL) | Changes from baseline biochemical parameters for nutritional status at 8 weeks | 
| Change on concentration of biochemical parameters for hormonal status | Thyroid Stimulating Hormone (µU/dL) | Changes from baseline biochemical parameters for hormonal status at 8 weeks | 
| Change on concentration of biochemical parameters for inflammation and cardiovascular risk | C-Reactive Protein (mg/dL) | Changes from baseline biochemical parameters for inflammation and cardiovascular risk at 8 weeks | 
| Change on concentration of biochemical parameters for inflammation and cardiovascular risk | Tumor Necrosis Factor-α (pg/mL), Inter Leukin-1β (pg/mL), Inter Leukin-6 (pg/mL) | Changes from baseline biochemical parameters for inflammation and cardiovascular risk at 8 weeks | 
| Change on concentration of biochemical parameters for inflammation and cardiovascular risk | Trimethylamine (µM), Trimethylamine-N-oxide (µM) | Changes from baseline biochemical parameters for inflammation and cardiovascular risk at 8 weeks | 
| Change on concentration of biochemical parameters for safety | Aspartate amino transferase (U/L), Alanine amino transferase (U/L), Gamma Glutamyl Transferase (U/L) | Changes from baseline biochemical parameters for safety at 8 weeks | 
| Change on concentration of biochemical parameters for safety | Creatinine (mg/dl) | Changes from baseline biochemical parameters for safety at 8 weeks | 
| Change on rate of anthropometric measures | Height (cm), waist circumference (cm) | Changes from baseline anthropometric measures at 8 weeks | 
| Change on rate of anthropometric measures | Weight (Kg) | Changes from baseline anthropometric measures at 8 weeks | 
| Change on rate of anthropometric measures | Body mass index (kg/m2) | Changes from baseline anthropometric measures at 8 weeks | 
| Change on rate of body composition | Free Fat Mass (kg), Fat Mass (kg) | Changes from baseline body composition at 8 weeks | 
| Change on rate of body composition | Android fat (%), Gynoid fat (%) | Changes from baseline body composition at 8 weeks | 
| Change on rate of body composition | Visceral Adipose Tissue (g) | Changes from baseline body composition at 8 weeks | 
| Change on status of mood assessment | 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. | Changes from baseline mood assessment at 8 weeks | 
| Change on status of assessment of food preferences | 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. | Changes from baseline assessment of food preferences at 8 weeks |