Obesity Class IIISynbioticNCT02958644
Effect of Synbiotic Supplement on the Body Mass Index of Participants With Severe Obesity
A study testing Synbiotics in people with Obesity Class III, run by Hospital Dona Helena at 3 sites in Brazil.
Trial summary
Obese patients have a high level of intestinal microflora imbalance, with serious consequences such as loss of digestive function. Potential mediators of intestinal microbiota are prebiotics, supplements considered safe because they are naturally contained in food and human microbiota. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity Class III
- What is being tested?
- Synbiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 3 sitesBrazil
- Study dates
- Sep 2017to Jul 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obesity class III (body mass index ≥40kg/m2)
Who cannot join
- Current use of prebiotics and probiotics or use in the last three months
- Intolerance to prebiotics and probiotics
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Hospital Dona Helena
Joinville, Santa Catarina, 89204-250
Micheli Arruda, R.N., +554734365500, micheli.c@donahelena.com.br
Hospital Regional Hans Dieter Schmidt
Joinville, Santa Catarina
Marilyn G Ferreira, PhD, +55 47 91029228, marilyn.ferreira@ielusc.br
Hospital do Coração
São Paulo, São Paulo, 04004-030
Bernardete Weber, PhD, bweber@hcor.com.br
About this study
Obese patients have a high level of intestinal microflora imbalance, with serious consequences such as loss of digestive function. Potential mediators of intestinal microbiota are prebiotics, supplements considered safe because they are naturally contained in food and human microbiota. Probiotics are living bacteria which are found in the normal gut microbiota. Synbiotics are combinations of both prebiotics and probiotics. Their use has been studied as a new therapeutic approach for the regulation of intestinal microbiota in various situations of disease, including severe obesity.
This is a double-blind, placebo-controlled, randomized clinical trial to assess the effect of synbiotic supplementation (fructo-oligosaccharide and probiotic - 12 g / day) on body mass index in participants with obesity class III, with follow up of 90 days.
Read the detailed description
Obesity has been discussed as one of the major diseases that require scientific and technological innovations for its control is obesity and studies indicate that microbiota of obese patients have a high level of intestinal microflora imbalance, with serious consequences such as loss of digestive function and the combination of toxins to protein.
Potential mediators of intestinal microbiota are prebiotics, probiotics and synbiotics, supplements considered safe because they are naturally contained in food and human microbiota. Its use has been studied as a new therapeutic approach for the regulation of intestinal microbiota in various situations of disease, including in severe obesity.
This study aims to analyze the effect of synbiotics supplementation on body mass index in participants diagnosed with morbid obesity. The methodology used is the randomized clinical trial, placebo-controlled with blinding of patients, healthcare staff and outcome assessors, with follow-up of 90 days.
Patients will be randomized into two groups: control group to receive placebo (polydextrose - 12 g / day) and synbiotic group - group supplemented with synbiotic (fructo-oligosaccharide and probiotics - 12 g / day). Probiotics are: Lactobacillus acidophilus; Lactobacillus rhamnosus; Lactobacillus paracasei; Bifïdobacterium lactis.
At the moments proposed in this study, will be conducted assessments of food intake, nutritional status and metabolic / inflammatory parameters (body mass index, high-sensitivity C-reactive protein, albumin, triglycerides, total cholesterol, HDL-cholesterol and LDL-cholesterol, fasting blood glucose, glycated hemoglobin, fasting insulin, weight, height).
- Conditions
- Obesity Class III
- Being tested
- Synbiotics, Placebo
- Keywords
- synbiotic, obesity, body mass index, microbiota
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticsDietary supplement
Also called Fructo-oligosaccharide and probiotics
12g / day synbiotics (fructo-oligosaccharide and probiotics) supplemented orally for 90 days
PlaceboDietary supplement
12g / day placebo (polydextrose) supplemented orally for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Synbiotics | Experimental | Synbiotics - 12g / day fructo-oligosaccharide and probiotics supplemented orally for 90 days. Receives: Dietary Supplement: Synbiotics |
| Placebo | Placebo comparator | Placebo - polydextrose 12g /day supplemented orally for 90 days.
The study supplements are packed in identical envelopes containing either 12g of oral powder fructo-oligosaccharide and probiotics or placebo to be diluted in water. The powder and the solution were identical in appearance, taste, and smell. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
Measured: 90 days
Secondary outcomes (14)
Plasma C-reactive protein
Measured: 90 days
Total cholesterol
Measured: 90 days
Plasma LDL-cholesterol
Measured: 90 days
Plasma HDL-cholesterol
Measured: 90 days
Plasma triglycerides
Measured: 90 days
Blood glucose
Fasting blood glucose
Measured: 90 days
Glycated hemoglobin
Measured: 90 days
Plasma insulin
Measured: 90 days
Arterial blood pressure
Systolic and diastolic arterial blood pressure
Measured: 90 days
Interleucin I-ß
Measured: 90 days
Interleucin 6
Measured: 90 days
Albumin
Measured: 90 days
Tumoral Necrose Factor (TNF-α)
Measured: 90 days
Adverse events
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startSep 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Class IIIStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Dona Helena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marilyn Gonçalves Ferreira Kuntz, Hospital Dona Helena
- Investigators
- Marilyn G Ferreira, PhD, Study chair, Hospital Dona Helena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958644
- Sponsor's protocol ID
- HDonaHelena
- Acronym
- Synbiotic
- Status last verified
- Sep 2017
- First submitted
- 4 Nov 2016
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the database containing de-identified individual participant data, data dictionary documentation, statistical analysis plan, and analysis code. Beginning 6 months following article publication, the trial steering committee will evaluate proposals of studies accompanied by a statistical analysis plan and may grant access to the data for approved proposals.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Synbiotic Supplement on the Body Mass Index of Participants With Severe Obesity
- ClinicalTrials.gov ID
- NCT02958644
- Acronym / sponsor ID
- Synbiotic / HDonaHelena
- Conditions
- Obesity Class III
- Keywords
- synbiotic, obesity, body mass index, microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hospital Dona HelenaUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 8 Nov 2016 (estimated)
- 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.
Obese patients have a high level of intestinal microflora imbalance, with serious consequences such as loss of digestive function. Potential mediators of intestinal microbiota are prebiotics, supplements considered safe because they are naturally contained in food and human microbiota. Probiotics are living bacteria which are found in the normal gut microbiota. Synbiotics are combinations of both prebiotics and probiotics. Their use has been studied as a new therapeutic approach for the regulation of intestinal microbiota in various situations of disease, including severe obesity.
This is a double-blind, placebo-controlled, randomized clinical trial to assess the effect of synbiotic supplementation (fructo-oligosaccharide and probiotic - 12 g / day) on body mass index in participants with obesity class III, with follow up of 90 days.
Detailed description
Obesity has been discussed as one of the major diseases that require scientific and technological innovations for its control is obesity and studies indicate that microbiota of obese patients have a high level of intestinal microflora imbalance, with serious consequences such as loss of digestive function and the combination of toxins to protein.
Potential mediators of intestinal microbiota are prebiotics, probiotics and synbiotics, supplements considered safe because they are naturally contained in food and human microbiota. Its use has been studied as a new therapeutic approach for the regulation of intestinal microbiota in various situations of disease, including in severe obesity.
This study aims to analyze the effect of synbiotics supplementation on body mass index in participants diagnosed with morbid obesity. The methodology used is the randomized clinical trial, placebo-controlled with blinding of patients, healthcare staff and outcome assessors, with follow-up of 90 days.
Patients will be randomized into two groups: control group to receive placebo (polydextrose - 12 g / day) and synbiotic group - group supplemented with synbiotic (fructo-oligosaccharide and probiotics - 12 g / day). Probiotics are: Lactobacillus acidophilus; Lactobacillus rhamnosus; Lactobacillus paracasei; Bifïdobacterium lactis.
At the moments proposed in this study, will be conducted assessments of food intake, nutritional status and metabolic / inflammatory parameters (body mass index, high-sensitivity C-reactive protein, albumin, triglycerides, total cholesterol, HDL-cholesterol and LDL-cholesterol, fasting blood glucose, glycated hemoglobin, fasting insulin, weight, height).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotics | Experimental | Dietary Supplement: SynbioticsSynbiotics - 12g / day fructo-oligosaccharide and probiotics supplemented orally for 90 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo - polydextrose 12g /day supplemented orally for 90 days. The study supplements are packed in identical envelopes containing either 12g of oral powder fructo-oligosaccharide and probiotics or placebo to be diluted in water. The powder and the solution were identical in appearance, taste, and smell. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obesity class III (body mass index ≥40kg/m2)
Key exclusion criteria (2 listed)
- Current use of prebiotics and probiotics or use in the last three months
- Intolerance to prebiotics and probiotics
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 |
|---|---|---|
| SynbioticsAlso: Fructo-oligosaccharide and probiotics12g / day synbiotics (fructo-oligosaccharide and probiotics) supplemented orally for 90 days | Dietary supplement | Synbiotics |
| Placebo12g / day placebo (polydextrose) supplemented orally for 90 days | Dietary supplement | Placebo |
Primary outcome
Body mass index
Time frame: 90 days
14 secondary outcomes
Plasma C-reactive protein
Time frame: 90 days
Total cholesterol
Time frame: 90 days
Plasma LDL-cholesterol
Time frame: 90 days
Plasma HDL-cholesterol
Time frame: 90 days
Plasma triglycerides
Time frame: 90 days
Blood glucose
Time frame: 90 days
Glycated hemoglobin
Time frame: 90 days
Plasma insulin
Time frame: 90 days
Arterial blood pressure
Time frame: 90 days
Interleucin I-ß
Time frame: 90 days
Interleucin 6
Time frame: 90 days
Albumin
Time frame: 90 days
Tumoral Necrose Factor (TNF-α)
Time frame: 90 days
Adverse events
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Individual participant dataSharing planned: Yes. We will share the database containing de-identified individual participant data, data dictionary documentation, statistical analysis plan, and analysis code. Beginning 6 months following article publication, the trial steering committee will evaluate proposals of studies accompanied by a statistical analysis plan and may grant access to the data for approved proposals.
Related trials for Obesity Class III
Not yet recruiting
High-Intensity Progressive Inspiratory Muscle Training in Class III Obesity and Obstructive Sleep Apnea
Obesity, Class III, Sleep Apnea, Obstructive
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.
Marilyn G Ferreira, PhD study chair
Hospital Dona Helena
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotics in people with Obesity Class III, run by Hospital Dona Helena at 3 sites in Brazil.
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 2 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: status not confirmed, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marilyn G Ferreira, PhD (+55 47 91029228, marilyn.ferreira@ielusc.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: 90 days). 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 19 Sep 2017; AzTrials last refreshed its copy on 7 Nov 2026.