ObesityNCT04919850
Effect of 60-days Saccharomyces Boulardii and Superoxide Dismutase Supplementation in Obese Adults
A study testing Saccharomyces boulardii and SOD in people with Obesity and Superoxide Dismutase, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Superoxide Dismutase
- What is being tested?
- Saccharomyces boulardii and SOD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2018to 20 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- I class of obesity (BMI: 30-35 Kg/m2)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Obesity, Superoxide Dismutase
- Being tested
- Saccharomyces boulardii and SOD, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboCombination product
A placebo consisting of capsules containing the same excipients except the active compounds, and the same coating
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on concentration of biochemical parameters for hunger sensation and hormonal status
Ghrelin (pg/mL), Adiponectin (pg/ml), Peptide YY (pg/ml)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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"
Measured: 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
Iron (µg/dL)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Changes from baseline biochemical parameters for safety at 8 weeks
Change on concentration of biochemical parameters for safety
Creatinine (mg/dl)
Measured: Changes from baseline biochemical parameters for safety at 8 weeks
Change on rate of anthropometric measures
Height (cm), waist circumference (cm)
Measured: Changes from baseline anthropometric measures at 8 weeks
Change on rate of anthropometric measures
Weight (Kg)
Measured: Changes from baseline anthropometric measures at 8 weeks
Change on rate of anthropometric measures
Body mass index (kg/m2)
Measured: Changes from baseline anthropometric measures at 8 weeks
Change on rate of body composition
Free Fat Mass (kg), Fat Mass (kg)
Measured: Changes from baseline body composition at 8 weeks
Change on rate of body composition
Android fat (%), Gynoid fat (%)
Measured: Changes from baseline body composition at 8 weeks
Change on rate of body composition
Visceral Adipose Tissue (g)
Measured: 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.
Measured: 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".
Measured: Changes from baseline assessment of food preferences at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start15 Jan 2018
- Primary completion28 Jan 2018
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariangela Rondanelli, Azienda di Servizi alla Persona di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919850
- Sponsor's protocol ID
- 1209/151217
- Status last verified
- Jun 2021
- First submitted
- 27 May 2021
- Last updated
- 9 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04919850
- Acronym / sponsor ID
- 1209/151217
- Conditions
- Obesity, Superoxide Dismutase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 28 Jan 2018 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Dietary Supplement: Saccharomyces boulardii and SODA complex of 250 mg of Saccharomyces boulardii and 500 IU SOD to be assumed twice/day for 8 weeks at mealtimes |
| Placebo group | Placebo comparator | Combination Product: PlaceboA placebo consisting of capsules containing the same excipients except the active compounds, and the same coating |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- I class of obesity (BMI: 30-35 Kg/m2)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saccharomyces boulardii and SODA complex of 250 mg of Saccharomyces boulardii and 500 IU SOD to be assumed twice/day for 8 weeks at mealtimes | Dietary supplement | Intervention group |
| PlaceboA placebo consisting of capsules containing the same excipients except the active compounds, and the same coating | Combination product | Placebo group |
Primary outcome
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)
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)
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)
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)
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)
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)
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)
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"
15 secondary outcomes
Change on concentration of biochemical parameters for nutritional status
Time frame: Changes from baseline biochemical parameters for nutritional status at 8 weeks
Change on concentration of biochemical parameters for hormonal status
Time frame: Changes from baseline biochemical parameters for hormonal status at 8 weeks
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
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
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
Change on concentration of biochemical parameters for safety
Time frame: Changes from baseline biochemical parameters for safety at 8 weeks
Change on concentration of biochemical parameters for safety
Time frame: Changes from baseline biochemical parameters for safety at 8 weeks
Change on rate of anthropometric measures
Time frame: Changes from baseline anthropometric measures at 8 weeks
Change on rate of anthropometric measures
Time frame: Changes from baseline anthropometric measures at 8 weeks
Change on rate of anthropometric measures
Time frame: Changes from baseline anthropometric measures at 8 weeks
Change on rate of body composition
Time frame: Changes from baseline body composition at 8 weeks
Change on rate of body composition
Time frame: Changes from baseline body composition at 8 weeks
Change on rate of body composition
Time frame: Changes from baseline body composition at 8 weeks
Change on status of mood assessment
Time frame: Changes from baseline mood assessment at 8 weeks
Change on status of assessment of food preferences
Time frame: Changes from baseline assessment of food preferences at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saccharomyces boulardii and SOD in people with Obesity and Superoxide Dismutase, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.