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

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).

Study Overview

• Status: Completed
• Conditions: Obesity; Superoxide Dismutase
• Intervention / Treatment: Dietary supplement: Saccharomyces boulardii and SOD; Combination product: Placebo

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Azienda di Servizi alla Persona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; 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; A complex of 250 mg of Saccharomyces boulardii and 500 IU SOD to be assumed twice/day for 8 weeks at mealtimes
Placebo Comparator: Placebo group; A placebo consisting of capsules containing the same excipients except the active compounds, and the same coating	Combination product: Placebo; A placebo consisting of capsules containing the same excipients except the active compounds, and the same coating

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change on concentration of biochemical parameters for nutritional status	Iron (µg/dL)	Changes from baseline biochemical parameters for nutritional status at 8 weeks
Change on concentration of biochemical parameters for hormonal status	Thyroid Stimulating Hormone (µU/dL)	Changes from baseline biochemical parameters for hormonal status at 8 weeks
Change on concentration of biochemical parameters for inflammation and cardiovascular risk	C-Reactive Protein (mg/dL)	Changes from baseline biochemical parameters for inflammation and cardiovascular risk at 8 weeks
Change on concentration of biochemical parameters for inflammation and cardiovascular risk	Tumor Necrosis Factor-α (pg/mL), Inter Leukin-1β (pg/mL), Inter Leukin-6 (pg/mL)	Changes from baseline biochemical parameters for inflammation and cardiovascular risk at 8 weeks
Change on concentration of biochemical parameters for inflammation and cardiovascular risk	Trimethylamine (µM), Trimethylamine-N-oxide (µM)	Changes from baseline biochemical parameters for inflammation and cardiovascular risk at 8 weeks
Change on concentration of biochemical parameters for safety	Aspartate amino transferase (U/L), Alanine amino transferase (U/L), Gamma Glutamyl Transferase (U/L)	Changes from baseline biochemical parameters for safety at 8 weeks
Change on concentration of biochemical parameters for safety	Creatinine (mg/dl)	Changes from baseline biochemical parameters for safety at 8 weeks
Change on rate of anthropometric measures	Height (cm), waist circumference (cm)	Changes from baseline anthropometric measures at 8 weeks
Change on rate of anthropometric measures	Weight (Kg)	Changes from baseline anthropometric measures at 8 weeks
Change on rate of anthropometric measures	Body mass index (kg/m2)	Changes from baseline anthropometric measures at 8 weeks
Change on rate of body composition	Free Fat Mass (kg), Fat Mass (kg)	Changes from baseline body composition at 8 weeks
Change on rate of body composition	Android fat (%), Gynoid fat (%)	Changes from baseline body composition at 8 weeks
Change on rate of body composition	Visceral Adipose Tissue (g)	Changes from baseline body composition at 8 weeks
Change on status of mood assessment	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.	Changes from baseline mood assessment at 8 weeks
Change on status of assessment of food preferences	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".	Changes from baseline assessment of food preferences at 8 weeks

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): January 28, 2018
• Study Completion (Actual): June 20, 2020

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 1209/151217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No