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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04919850
• Other study ID #: 1209/151217
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: June 20, 2020

Study information

• Verified date: June 2021
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 20, 2020
• Est. primary completion date: January 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Superoxide Dismutase

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda di Servizi alla Persona	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change on concentration of biochemical parameters for nutritional status	Iron (µg/dL)	Changes from baseline biochemical parameters for nutritional status at 8 weeks
Secondary	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
Secondary	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
Secondary	Change on concentration of biochemical parameters for inflammation and cardiovascular risk	Tumor Necrosis Factor-a (pg/mL), Inter Leukin-1ß (pg/mL), Inter Leukin-6 (pg/mL)	Changes from baseline biochemical parameters for inflammation and cardiovascular risk at 8 weeks
Secondary	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
Secondary	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
Secondary	Change on concentration of biochemical parameters for safety	Creatinine (mg/dl)	Changes from baseline biochemical parameters for safety at 8 weeks
Secondary	Change on rate of anthropometric measures	Height (cm), waist circumference (cm)	Changes from baseline anthropometric measures at 8 weeks
Secondary	Change on rate of anthropometric measures	Weight (Kg)	Changes from baseline anthropometric measures at 8 weeks
Secondary	Change on rate of anthropometric measures	Body mass index (kg/m2)	Changes from baseline anthropometric measures at 8 weeks
Secondary	Change on rate of body composition	Free Fat Mass (kg), Fat Mass (kg)	Changes from baseline body composition at 8 weeks
Secondary	Change on rate of body composition	Android fat (%), Gynoid fat (%)	Changes from baseline body composition at 8 weeks
Secondary	Change on rate of body composition	Visceral Adipose Tissue (g)	Changes from baseline body composition at 8 weeks
Secondary	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
Secondary	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