NCT04919850

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2018

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2018

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
Last Updated

June 9, 2021

Status Verified

June 1, 2021

Enrollment Period

13 days

First QC Date

May 27, 2021

Last Update Submit

June 3, 2021

Conditions

ObesitySuperoxide Dismutase

Outcome Measures

Primary Outcomes (8)

  • Change on concentration of biochemical parameters for hunger sensation and hormonal status

    Ghrelin (pg/mL), Adiponectin (pg/ml), Peptide YY (pg/ml)

    Changes from baseline biochemical parameters for hunger sensation and hormonal status at 8 weeks

  • Change on concentration of biochemical parameters for hunger sensation and hormonal status

    Leptin (ng/cL)

    Changes from baseline biochemical parameters for hunger sensation and hormonal status at 8 weeks

  • Change on concentration of biochemical parameters for hunger sensation and hormonal status

    glucagon-like peptide - 1 (pmol/L)

    Changes from baseline biochemical parameters for hunger sensation and hormonal status at 8 weeks

  • Change on concentration of biochemical parameters for glico-metabolic status

    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)

    Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks

  • Change on concentration of biochemical parameters for glico-metabolic status

    Insulin (mcU/mL)

    Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks

  • Change on concentration of biochemical parameters for glico-metabolic status

    Total Proteins (g/dL), Albumin (g/dL)

    Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks

  • Change on concentration of biochemical parameters for glico-metabolic status

    HOMA index (pt)

    Changes from baseline biochemical parameters for glico-metabolic status at 8 weeks

  • Change on state of hunger, fullness, desire to eat, satiety and prospective food consumption

    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"

    Changes from baseline state of hunger, fullness, desire to eat, satiety and prospective food consumption at 8 weeks

Secondary Outcomes (15)

  • Change on concentration of biochemical parameters for nutritional status

    Changes from baseline biochemical parameters for nutritional status at 8 weeks

  • Change on concentration of biochemical parameters for hormonal status

    Changes from baseline biochemical parameters for hormonal status at 8 weeks

  • Change on concentration of biochemical parameters for inflammation and cardiovascular risk

    Changes from baseline biochemical parameters for inflammation and cardiovascular risk at 8 weeks

  • Change on concentration of biochemical parameters for inflammation and cardiovascular risk

    Changes from baseline biochemical parameters for inflammation and cardiovascular risk at 8 weeks

  • Change on concentration of biochemical parameters for inflammation and cardiovascular risk

    Changes from baseline biochemical parameters for inflammation and cardiovascular risk at 8 weeks

  • +10 more secondary outcomes

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Dietary Supplement: Saccharomyces boulardii and SOD

Placebo group

PLACEBO COMPARATOR

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

Combination Product: Placebo

Interventions

Saccharomyces boulardii and SODDIETARY_SUPPLEMENT

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

Intervention group
PlaceboCOMBINATION_PRODUCT

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

Placebo group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • I class of obesity (BMI: 30-35 Kg/m2)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda di Servizi alla Persona

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Obesity

Interventions

Superoxide Dismutase

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OxidoreductasesEnzymesEnzymes and Coenzymes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 27, 2021

First Posted

June 9, 2021

Study Start

January 15, 2018

Primary Completion

January 28, 2018

Study Completion

June 20, 2020

Last Updated

June 9, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)