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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04919850
Other study ID # 1209/151217
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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