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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
A complex of 250 mg of Saccharomyces boulardii and 500 IU SOD to be assumed twice/day for 8 weeks at mealtimes
A placebo consisting of capsules containing the same excipients except the active compounds, and the same coating
Azienda di Servizi alla Persona
Pavia, Italy
Change on concentration of biochemical parameters for hunger sensation and hormonal status
Ghrelin (pg/mL), Adiponectin (pg/ml), Peptide YY (pg/ml)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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"
Time frame: Changes from baseline state of hunger, fullness, desire to eat, satiety and prospective food consumption at 8 weeks
Change on concentration of biochemical parameters for nutritional status
Iron (µg/dL)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Changes from baseline biochemical parameters for safety at 8 weeks
Change on concentration of biochemical parameters for safety
Creatinine (mg/dl)
Time frame: Changes from baseline biochemical parameters for safety at 8 weeks
Change on rate of anthropometric measures
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Height (cm), waist circumference (cm)
Time frame: Changes from baseline anthropometric measures at 8 weeks
Change on rate of anthropometric measures
Weight (Kg)
Time frame: Changes from baseline anthropometric measures at 8 weeks
Change on rate of anthropometric measures
Body mass index (kg/m2)
Time frame: Changes from baseline anthropometric measures at 8 weeks
Change on rate of body composition
Free Fat Mass (kg), Fat Mass (kg)
Time frame: Changes from baseline body composition at 8 weeks
Change on rate of body composition
Android fat (%), Gynoid fat (%)
Time frame: Changes from baseline body composition at 8 weeks
Change on rate of body composition
Visceral Adipose Tissue (g)
Time frame: 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.
Time frame: 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".
Time frame: Changes from baseline assessment of food preferences at 8 weeks