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

Azienda di Servizi alla Persona di Pavia

Status: Completed

Conditions: Superoxide Dismutase; Obesity

Treatments: Dietary Supplement: Saccharomyces boulardii and SOD; Combination Product: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04919850

1209/151217

Details and patient eligibility

About

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).

Enrollment: 25 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

Intervention group

Active Comparator group

Description:

A complex of 250 mg of Saccharomyces boulardii and 500 IU SOD to be assumed twice/day for 8 weeks at mealtimes

Treatment:

Dietary Supplement: Saccharomyces boulardii and SOD

Placebo group

Placebo Comparator group

Description:

A placebo consisting of capsules containing the same excipients except the active compounds, and the same coating

Treatment:

Combination Product: Placebo