Effect of 60-days Saccharomyces Boulardii and Superoxide Dismutase Supplementation in Obese Adults
- Conditions
- Superoxide DismutaseObesity
- Interventions
- Dietary Supplement: Saccharomyces boulardii and SODCombination Product: Placebo
- Registration Number
- NCT04919850
- Lead Sponsor
- Azienda di Servizi alla Persona di Pavia
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- I class of obesity (BMI: 30-35 Kg/m2)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Saccharomyces 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 Placebo group Placebo A placebo consisting of capsules containing the same excipients except the active compounds, and the same coating
- Primary Outcome Measures
Name Time Method 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 glucagon-like peptide - 1 (pmol/L)
Change on concentration of biochemical parameters for glico-metabolic status Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks HOMA index (pt)
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 Outcome Measures
Name Time Method 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 Trimethylamine (µM), Trimethylamine-N-oxide (µM)
Change on concentration of biochemical parameters for safety Changes from baseline biochemical parameters for safety at 8 weeks Creatinine (mg/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 concentration of biochemical parameters for nutritional status Changes from baseline biochemical parameters for nutritional status at 8 weeks Iron (µg/dL)
Change on rate of anthropometric measures Changes from baseline anthropometric measures at 8 weeks Body mass index (kg/m2)
Change on rate of body composition Changes from baseline body composition at 8 weeks Visceral Adipose Tissue (g)
Trial Locations
- Locations (1)
Azienda di Servizi alla Persona
🇮🇹Pavia, Italy