Trials / Completed
CompletedNCT04919850
Effect of 60-days Saccharomyces Boulardii and Superoxide Dismutase Supplementation in Obese Adults
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Azienda di Servizi alla Persona di Pavia · Academic / Other
- Sex
- All
- Age
- 30 Years – 65 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | 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 |
| COMBINATION_PRODUCT | Placebo | A placebo consisting of capsules containing the same excipients except the active compounds, and the same coating |
Timeline
- Start date
- 2018-01-15
- Primary completion
- 2018-01-28
- Completion
- 2020-06-20
- First posted
- 2021-06-09
- Last updated
- 2021-06-09
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04919850. Inclusion in this directory is not an endorsement.