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

NCT ID: NCT04919850

Last Updated: 2021-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2020-06-20

Brief Summary

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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

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Conditions

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Obesity Superoxide Dismutase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention group

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

Group Type ACTIVE_COMPARATOR

Saccharomyces boulardii and SOD

Intervention Type DIETARY_SUPPLEMENT

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

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type COMBINATION_PRODUCT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azienda di Servizi alla Persona di Pavia

OTHER

Sponsor Role lead

Responsible Party

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Mariangela Rondanelli

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda di Servizi alla Persona

Pavia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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1209/151217

Identifier Type: -

Identifier Source: org_study_id

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