Obesity, Superoxide Dismutase
Conditions
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).
Interventions
DIETARY_SUPPLEMENTSaccharomyces boulardii and SOD
A complex of 250 mg of Saccharomyces boulardii and 500 IU SOD to be assumed twice/day for 8 weeks at mealtimes
COMBINATION_PRODUCTPlacebo
A placebo consisting of capsules containing the same excipients except the active compounds, and the same coating
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change on concentration of biochemical parameters for hunger sensation and hormonal status | Changes from baseline biochemical parameters for hunger sensation and hormonal status at 8 weeks | Ghrelin (pg/mL), Adiponectin (pg/ml), Peptide YY (pg/ml) |
| Change on concentration of biochemical parameters for glico-metabolic status | Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks | 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) |
| Change on state of hunger, fullness, desire to eat, satiety and prospective food consumption | Changes from baseline state of hunger, fullness, desire to eat, satiety and prospective food consumption at 8 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change on concentration of biochemical parameters for safety | Changes from baseline biochemical parameters for safety at 8 weeks | Aspartate amino transferase (U/L), Alanine amino transferase (U/L), Gamma Glutamyl Transferase (U/L) |
| Change on rate of anthropometric measures | Changes from baseline anthropometric measures at 8 weeks | Height (cm), waist circumference (cm) |
| Change on concentration of biochemical parameters for nutritional status | Changes from baseline biochemical parameters for nutritional status at 8 weeks | Iron (µg/dL) |
| Change on status of mood assessment | Changes from baseline mood assessment at 8 weeks | 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. |
| Change on status of assessment of food preferences | Changes from baseline assessment of food preferences at 8 weeks | 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. |
| Change on rate of body composition | Changes from baseline body composition at 8 weeks | Free Fat Mass (kg), Fat Mass (kg) |
| Change on concentration of biochemical parameters for hormonal status | Changes from baseline biochemical parameters for hormonal status at 8 weeks | Thyroid Stimulating Hormone (µU/dL) |
| Change on concentration of biochemical parameters for inflammation and cardiovascular risk | Changes from baseline biochemical parameters for inflammation and cardiovascular risk at 8 weeks | C-Reactive Protein (mg/dL) |
Countries
Italy
Outcome results
None listed