ObesityNCT02505854
Influence of Probiotic and Symbiotic in Body Weight, Blood Sugar and Lipemia of Obese Women
A study testing Probiotic and Symbiotic in people with Obesity, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate whether gut microbiota modulation by probiotic and symbiotic contribute with weight loss and improvement of metabolic parameters in women with obesity. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Probiotic and Symbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to Nov 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women;
- Adult;
- Obese (BMI between 30 and 39,9 Kg/m²).
Who cannot join
- Pregnancy or nursing;
- Smokers;
- Drinkers;
- Use of drug or phytotherapic;
- Diagnosis of any cronic disease;
- Daily consumption of yogurt.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate whether gut microbiota modulation by probiotic and symbiotic contribute with weight loss and improvement of metabolic parameters in women with obesity.
Read the detailed description
We will evaluate the effects of probiotic and symbiotic on weigh loss, blood glucose, lipid profile, metabolomic profile, and gut microbiota composition variables in women with obesity.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called Bifidobacterium lactis
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of maltodextrin
SymbioticDietary supplement
Also called Bifidobacterium lactis and fructooligosaccharide
Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of fructooligosaccharide
PlaceboDietary supplement
Also called Gelatin
Hypocaloric diet associated with capsule containing 50g of gelatin and sache of maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of maltodextrin Receives: Dietary Supplement: Probiotic |
| Symbiotic | Active comparator | Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of fructooligosaccharide Receives: Dietary Supplement: Symbiotic |
| Placebo | Placebo comparator | Hypocaloric diet associated with capsule containing 50g of gelatin and sache with 5 g of maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of probiotic and symbiotic on weight loss of women obese
Determine and evaluate change in body weight and body mass index after intervention.
Measured: Baseline and 60 days and 15 days after the end of the intervention
Secondary outcomes (8)
Effect of probiotic and symbiotic on blood glucose
Determine and comparing the blood glucose in plasma before and after intervention
Measured: Baseline, 60 days and 15 days after the end of the intervention
Effect of probiotic and symbiotic on insulin resistance
Compare insulin resistance through HOMA-IR calculation before and after intervention and evaluate whether the intervention improvement in this parameter.
Measured: Baseline and 60 days
Effect of probiotic and symbiotic on lipid profile
Compare lipid profile (total cholesterol, low-density lipoprotein, high-density lipoprotein, very low-density lipoprotein, triglyceride) in serum of blood before and after intervention and evaluate whether the intervention improvement in this parameter.
Measured: Baseline and 60 days
Effect probiotic and symbiotic on blood pressure
Determine blood pressure and evaluate whether the intervention improvement blood pressure.
Measured: Baseline,60 days and 15 days after intervention conclusion
Effect of probiotic and symbiotic on gut microbiota composition
Determine and comparing the amount filos (Fimicutes, Bacteroidetes, Actinobacteria, Verrucomicrobia e Proteobacteria) in gut microbiota and whether the change in microbiota composition continue after stop probiotic and symbiotic intake
Measured: Baseline, 60 days and 15 days after intervention conclusion
Effect of probiotic and symbiotic on stool consitency by Bristol scale
Determine and comparing the stool consistency by Bristol scale. The Bristol scale is composed of 7 different stool consistency, being 1 and 2 lumpy, 3 and 4 normal, 5 to 7 loose.
Measured: Baseline,60 days and 15 days after intervention conclusion
Effect of probiotic and symbiotic on gastrointestinal symptons
Evaluate the presence of gastrointestinal symptoms related to the probiotic and symbiotic. The gastrointestinal symptoms analyzed were abdominal pains, abdominal distension and abdominal discomfort, flatus, borborygmus using the Likert scale of 5 point, which 0 is absence of symptom and 4 is every day.
Measured: Baseline,60 days and 15 days after intervention conclusion
Effect of probiotic and symbiotic on metabolomic profile
Determine and comparing change in metabolomic profile before and after intervention. The metabolomic profile was evaluated in the serum of blood Bruker DRX 500 MHz equipment (Bruker Spectrospin, Karlsruhe, Germany) generating hydrogen isotope 1 (1H)-NMR spectra, that was compared to database Human Metabolome Data Base.
Measured: Baseline and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Louise Crovesy de Oliveira, Universidade Federal do Rio de Janeiro
- Investigators
- Louise C Oliveira, MD student, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505854
- Sponsor's protocol ID
- CEP 104-14
- Status last verified
- Dec 2019
- First submitted
- 16 Jul 2015
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Crovesy L, El-Bacha T, Rosado EL. Modulation of the gut microbiota by probiotics and symbiotics is associated with changes in serum metabolite profile related to a decrease in inflammation and overall benefits to metabolic health: a double-blind randomized controlled clinical trial in women with obesity. Food Funct. 2021 Mar 15;12(5):2161-2170. doi: 10.1039/d0fo02748k.
PubMed 33565558
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Probiotic and Symbiotic in Body Weight, Blood Sugar and Lipemia of Obese Women
- ClinicalTrials.gov ID
- NCT02505854
- Acronym / sponsor ID
- CEP 104-14
- Conditions
- Obesity
- Keywords
- Obesity, Probiotic, Symbiotic, Weight loss, Gut microbiota, Bifidobacterium lactis, Fructooligosaccharide, Blood sugar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 22 Jul 2015 (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.
The purpose of this study is to evaluate whether gut microbiota modulation by probiotic and symbiotic contribute with weight loss and improvement of metabolic parameters in women with obesity.
Detailed description
We will evaluate the effects of probiotic and symbiotic on weigh loss, blood glucose, lipid profile, metabolomic profile, and gut microbiota composition variables in women with obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: ProbioticHypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of maltodextrin |
| Symbiotic | Active comparator | Dietary Supplement: SymbioticHypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache with 5 g of fructooligosaccharide |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboHypocaloric diet associated with capsule containing 50g of gelatin and sache with 5 g of maltodextrin |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women;
- Adult;
- Obese (BMI between 30 and 39,9 Kg/m²).
Key exclusion criteria (6 listed)
- Pregnancy or nursing;
- Smokers;
- Drinkers;
- Use of drug or phytotherapic;
- Diagnosis of any cronic disease;
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 |
|---|---|---|
| ProbioticAlso: Bifidobacterium lactisHypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of maltodextrin | Dietary supplement | Probiotic |
| SymbioticAlso: Bifidobacterium lactis and fructooligosaccharideHypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of fructooligosaccharide | Dietary supplement | Symbiotic |
| PlaceboAlso: GelatinHypocaloric diet associated with capsule containing 50g of gelatin and sache of maltodextrin | Dietary supplement | Placebo |
Primary outcome
Evaluate the effect of probiotic and symbiotic on weight loss of women obese
Time frame: Baseline and 60 days and 15 days after the end of the intervention
Determine and evaluate change in body weight and body mass index after intervention.
8 secondary outcomes
Effect of probiotic and symbiotic on blood glucose
Time frame: Baseline, 60 days and 15 days after the end of the intervention
Effect of probiotic and symbiotic on insulin resistance
Time frame: Baseline and 60 days
Effect of probiotic and symbiotic on lipid profile
Time frame: Baseline and 60 days
Effect probiotic and symbiotic on blood pressure
Time frame: Baseline,60 days and 15 days after intervention conclusion
Effect of probiotic and symbiotic on gut microbiota composition
Time frame: Baseline, 60 days and 15 days after intervention conclusion
Effect of probiotic and symbiotic on stool consitency by Bristol scale
Time frame: Baseline,60 days and 15 days after intervention conclusion
Effect of probiotic and symbiotic on gastrointestinal symptons
Time frame: Baseline,60 days and 15 days after intervention conclusion
Effect of probiotic and symbiotic on metabolomic profile
Time frame: Baseline and 60 days
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 10 Dec 2019.
- Derived from this study: PubMed 33565558Crovesy L, El-Bacha T, Rosado EL. Modulation of the gut microbiota by probiotics and symbiotics is associated with changes in serum metabolite profile related to a decrease in inflammation and overall benefits to metabolic health: a double-blind randomized controlled clinical trial in women with obesity. Food Funct. 2021 Mar 15;12(5):2161-2170. doi: 10.1039/d0fo02748k.
- Institute of Nutrition Josué de CastroLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Louise C Oliveira, MD student principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic and Symbiotic in people with Obesity, run by Universidade Federal do Rio de Janeiro at 1 site 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 3 inclusion and 6 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 10 Dec 2019. 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 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?
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?
Evaluate the effect of probiotic and symbiotic on weight loss of women obese (time frame: Baseline and 60 days and 15 days after the end of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02505854, which also lists 1 linked publication.
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 10 Dec 2019.