Skip to main content
OpenTrials
Completed

NCT Number: NCT04919850

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda di Servizi alla Persona

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saccharomyces boulardii and SOD

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

Combination Product

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

Primary outcomes

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

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

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

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

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

    Leptin (ng/cL)

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

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

    glucagon-like peptide - 1 (pmol/L)

  4. Change on concentration of biochemical parameters for glico-metabolic status

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

    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)

  5. Change on concentration of biochemical parameters for glico-metabolic status

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

    Insulin (mcU/mL)

  6. Change on concentration of biochemical parameters for glico-metabolic status

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

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

  7. Change on concentration of biochemical parameters for glico-metabolic status

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

    HOMA index (pt)

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

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

    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"

Secondary outcomes

  1. Change on concentration of biochemical parameters for nutritional status

    Time frame: Changes from baseline biochemical parameters for nutritional status at 8 weeks

    Iron (µg/dL)

  2. Change on concentration of biochemical parameters for hormonal status

    Time frame: Changes from baseline biochemical parameters for hormonal status at 8 weeks

    Thyroid Stimulating Hormone (µU/dL)

  3. Change on concentration of biochemical parameters for inflammation and cardiovascular risk

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

    C-Reactive Protein (mg/dL)

  4. Change on concentration of biochemical parameters for inflammation and cardiovascular risk

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

    Tumor Necrosis Factor-α (pg/mL), Inter Leukin-1β (pg/mL), Inter Leukin-6 (pg/mL)

  5. Change on concentration of biochemical parameters for inflammation and cardiovascular risk

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

    Trimethylamine (µM), Trimethylamine-N-oxide (µM)

  6. Change on concentration of biochemical parameters for safety

    Time frame: Changes from baseline biochemical parameters for safety at 8 weeks

    Aspartate amino transferase (U/L), Alanine amino transferase (U/L), Gamma Glutamyl Transferase (U/L)

  7. Change on concentration of biochemical parameters for safety

    Time frame: Changes from baseline biochemical parameters for safety at 8 weeks

    Creatinine (mg/dl)

  8. Change on rate of anthropometric measures

    Time frame: Changes from baseline anthropometric measures at 8 weeks

    Height (cm), waist circumference (cm)

  9. Change on rate of anthropometric measures

    Time frame: Changes from baseline anthropometric measures at 8 weeks

    Weight (Kg)

  10. Change on rate of anthropometric measures

    Time frame: Changes from baseline anthropometric measures at 8 weeks

    Body mass index (kg/m2)

  11. Change on rate of body composition

    Time frame: Changes from baseline body composition at 8 weeks

    Free Fat Mass (kg), Fat Mass (kg)

  12. Change on rate of body composition

    Time frame: Changes from baseline body composition at 8 weeks

    Android fat (%), Gynoid fat (%)

  13. Change on rate of body composition

    Time frame: Changes from baseline body composition at 8 weeks

    Visceral Adipose Tissue (g)

  14. Change on status of mood assessment

    Time frame: Changes from baseline mood assessment at 8 weeks

    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.

  15. Change on status of assessment of food preferences

    Time frame: Changes from baseline assessment of food preferences at 8 weeks

    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".

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Jun 9, 2021
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.