ObesityPhase 3BIFFATNCT02921217
Effect of a Probiotic on Visceral Fat Accumulation
A Phase 3 study testing Active Probiotic and Inactivated probiotic in people with Obesity and Intra-Abdominal Fat, run by Biopolis S.L. at 1 site in Spain.
Trial summary
The study's main objective is to investigate if an extract containing the probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) has a positive effect on the accumulation of abdominal visceral fat in people with abdominal obesity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Intra-Abdominal Fat, Subcutaneous Fat, Abdominal
- What is being tested?
- Active Probiotic and Inactivated probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2016to Aug 2017
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults men or women (>18 years old)
- Waist circumference ≥102 cm (men) or ≥88 cm (women) and <150cm
- Written informed consent provided before the initial screening visit.
Who cannot join
- Use of antibiotics within 30-days period before the study
- Waist circumference other than those specified in inclusion criteria
- Body mass index (BMI) ≥ 40 kg/m2
- Glucose (fasting state) ≥ 126 mg/dL
- Anemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women)
- Suffer from claustrophobia (to the extent that precludes NMR).
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- Wear pacemakers, electrical stimulators or cochlear implants (NMR contraindications)
- Following a hypocaloric diet and/or receiving pharmacologic treatment for weight loss
- Having eating disorders.
- Use of medication, antioxidant, or multi-vitamin supplements interfering with the study
- Chronic gastrointestinal pathology
- Being intolerant or suffer from allergy to any of the products of the study.
- Pregnant or intending to become pregnant
- Being in breastfeeding period.
- Chronic alcoholism
- Current or past participation in a clinical trial or consumption of a research product in the 30 days prior to inclusion in the study.
- Failing to follow study guidelines.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Technological Centre of Nutrition and Health (CTNS)
Reus, Tarragona, 43204
Rosa Maria Valls, PhD, +34 636 944 723, estudis@ctns.cat
Anna Pedret, PhD
About this study
Official title: Randomized, Parallel, Double Blinded, Placebo-controlled Study for the Evaluation of the Effectiveness on Visceral Fat Accumulation in Individuals With Abdominal Obesity of a Specific Probiotic Compound
The study's main objective is to investigate if an extract containing the probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) has a positive effect on the accumulation of abdominal visceral fat in people with abdominal obesity.
Read the detailed description
The study's main objective is to investigate if an extract containing the probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) has a positive effect on the accumulation of abdominal visceral fat in people with abdominal obesity.
Participants: 129 men and women with a waist circumference ≥102 cm (men) or ≥88 cm (women), randomly assigned to one of 3 treatment groups in parallel: one group (43 members) with active probiotic, another one with the probiotic inactivated by heat, and the last group with the placebo.
Treatment consists of product consumption study for 12 weeks, taking 1 capsule per day. 4 visits during the study, a pre-inclusion visit and 3 study visits (weeks 1, 6, and 12) will be scheduled.
Secondary objectives are to asses the probiotic's effects on:
- the accumulation of subcutaneous body fat and body weight, body mass index (BMI) and waist circumference.
- glucose metabolism and insulin resistance.
- blood lipid profile.
- blood pressure.
- inflammation.
- circulating levels of adiponectin and leptin.
- changes in the intestinal microbiome
The statistical analysis will follow the principles specified in the guidelines of the ICHE9 and CPMP/EWP/908/99 ICHE9 Points to Consider on Multiplicity Issues in Clinical Trials.
- Conditions
- Obesity, Intra-Abdominal Fat, Subcutaneous Fat, Abdominal
- Being tested
- Active Probiotic, Inactivated probiotic, Control
- Keywords
- Cardiovascular diseases, abdominal visceral fat, subcutaneous body fat, body weight, waist circumference, lipid profile, insulin resistance, glucose metabolism, blood pressure, inflammation, adiponectin, leptin, metabolomics, cardiovascular risk factor
- Medical subject headings
- Obesity, Cardiovascular Diseases, Body Weight, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ProbioticDietary supplement
Product 1: 200 mg maltodextrin and 100 mg of active Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) (1011 CFU/g),
Inactivated probioticDietary supplement
Product 1: 200 mg maltodextrin and 100 mg of Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) inactivated by heat (1011 CFU/g),
ControlDietary supplement
Placebo: 300 mg maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| ActivBPL1 | Experimental | Active Probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) Receives: Dietary Supplement: Active Probiotic |
| InactivBPL1 | Experimental | Inactivated probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) Receives: Dietary Supplement: Inactivated probiotic |
| Control | Placebo comparator | Control Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of abdominal visceral fat
abdominal visceral fat will be measured by Nuclear Magnetic Resonance (NMR). The study will be conducted in 3 Teslas MRI (Signa LX Echo Speed Plus Excite, General Electric, Milwaukee, WI).
Measured: Change from 0 weeks (V1) to 12 weeks (V3)
Secondary outcomes (4)
Change of body weight
Body weight measured with Tanita TBF-300 (Body Composition Analyzer, Brooklyn NY, USA)
Measured: Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
Change of BMI
Calculated using weight and height. Body weight measured with Tanita TBF-300 (Body Composition Analyzer, Brooklyn NY, USA). Height, measured by Tanita portable altimeter; BMI calculated (kg/m2)
Measured: Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
Change of Waist circumference
Waist circumference, measured according to the criteria of Lohman et al. 1988.
Measured: Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
Change of Abdominal subcutaneous fat
Abdominal subcutaneous fat measured by 3 Teslas MRI (Signa LX Echo Speed Plus Excite, General Electric, Milwaukee, WI).
Measured: Change from 0 weeks (V1) to 12 weeks (V3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionMay 2017 (estimated)
- Study completionAug 2017 (estimated)
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biopolis S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Technological Centre of Nutrition and Health, Hospital Universitari Sant Joan de Reus, University Rovira i Virgili
- Responsible party
- Sponsor
- Investigators
- Rosa Solà, Prof. MD, Principal investigator, University Rovira i Virgili / Hospital Universitari Sant Joan de Reus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921217
- Sponsor's protocol ID
- BIFFAT
- Acronym
- BIFFAT
- Status last verified
- Sep 2016
- First submitted
- 20 Jul 2016
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Vaccaro O, Masulli M, Cuomo V, Rivellese AA, Uusitupa M, Vessby B, Hermansen K, Tapsell L, Riccardi G. Comparative evaluation of simple indices of insulin resistance. Metabolism. 2004 Dec;53(12):1522-6. doi: 10.1016/j.metabol.2004.05.017.
PubMed 15562393
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Parallel, Double Blinded, Placebo-controlled Study for the Evaluation of the Effectiveness on Visceral Fat Accumulation in Individuals With Abdominal Obesity of a Specific Probiotic Compound
- ClinicalTrials.gov ID
- NCT02921217
- Acronym / sponsor ID
- BIFFAT / BIFFAT
- Conditions
- Obesity, Intra-Abdominal Fat, Subcutaneous Fat, Abdominal
- Keywords
- Cardiovascular diseases, abdominal visceral fat, subcutaneous body fat, body weight, waist circumference, lipid profile, insulin resistance, glucose metabolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Biopolis S.L.Industry (pharma, biotech, devices)
- Collaborators
- Technological Centre of Nutrition and Health, Hospital Universitari Sant Joan de Reus, University Rovira i Virgili
- Study start
- Jul 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 3 Oct 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.
The study's main objective is to investigate if an extract containing the probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) has a positive effect on the accumulation of abdominal visceral fat in people with abdominal obesity.
Detailed description
The study's main objective is to investigate if an extract containing the probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) has a positive effect on the accumulation of abdominal visceral fat in people with abdominal obesity.
Participants: 129 men and women with a waist circumference ≥102 cm (men) or ≥88 cm (women), randomly assigned to one of 3 treatment groups in parallel: one group (43 members) with active probiotic, another one with the probiotic inactivated by heat, and the last group with the placebo.
Treatment consists of product consumption study for 12 weeks, taking 1 capsule per day. 4 visits during the study, a pre-inclusion visit and 3 study visits (weeks 1, 6, and 12) will be scheduled.
Secondary objectives are to asses the probiotic's effects on:
- the accumulation of subcutaneous body fat and body weight, body mass index (BMI) and waist circumference.
- glucose metabolism and insulin resistance.
- blood lipid profile.
- blood pressure.
- inflammation.
- circulating levels of adiponectin and leptin.
- changes in the intestinal microbiome
The statistical analysis will follow the principles specified in the guidelines of the ICHE9 and CPMP/EWP/908/99 ICHE9 Points to Consider on Multiplicity Issues in Clinical Trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ActivBPL1 | Experimental | Dietary Supplement: Active ProbioticActive Probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) |
| InactivBPL1 | Experimental | Dietary Supplement: Inactivated probioticInactivated probiotic Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) |
| Control | Placebo comparator | Dietary Supplement: ControlControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults men or women (>18 years old)
- Waist circumference ≥102 cm (men) or ≥88 cm (women) and <150cm
- Written informed consent provided before the initial screening visit.
Key exclusion criteria (17 listed)
- Use of antibiotics within 30-days period before the study
- Waist circumference other than those specified in inclusion criteria
- Body mass index (BMI) ≥ 40 kg/m2
- Glucose (fasting state) ≥ 126 mg/dL
- Anemia (hemoglobin ≤13 g/dL in men and ≤12 g/dL in women)
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 |
|---|---|---|
| Active ProbioticProduct 1: 200 mg maltodextrin and 100 mg of active Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) (1011 CFU/g), | Dietary supplement | ActivBPL1 |
| Inactivated probioticProduct 1: 200 mg maltodextrin and 100 mg of Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) inactivated by heat (1011 CFU/g), | Dietary supplement | InactivBPL1 |
| ControlPlacebo: 300 mg maltodextrin. | Dietary supplement | Control |
Primary outcome
Change of abdominal visceral fat
Time frame: Change from 0 weeks (V1) to 12 weeks (V3)
abdominal visceral fat will be measured by Nuclear Magnetic Resonance (NMR). The study will be conducted in 3 Teslas MRI (Signa LX Echo Speed Plus Excite, General Electric, Milwaukee, WI).
4 secondary outcomes
Change of body weight
Time frame: Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
Change of BMI
Time frame: Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
Change of Waist circumference
Time frame: Change from 0 weeks (V1) to 6 weeks (V2), and to 12 weeks (V3)
Change of Abdominal subcutaneous fat
Time frame: Change from 0 weeks (V1) to 12 weeks (V3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- Background: PubMed 15562393Vaccaro O, Masulli M, Cuomo V, Rivellese AA, Uusitupa M, Vessby B, Hermansen K, Tapsell L, Riccardi G. Comparative evaluation of simple indices of insulin resistance. Metabolism. 2004 Dec;53(12):1522-6. doi: 10.1016/j.metabol.2004.05.017.
- Technological Centre of Nutrition and HealthLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Rosa Solà, Prof. MD principal investigator
University Rovira i Virgili / Hospital Universitari Sant Joan de Reus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active Probiotic and Inactivated probiotic in people with Obesity and Intra-Abdominal Fat, run by Biopolis S.L. at 1 site in Spain.
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 17 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 3 Oct 2016. 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 Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rosa Maria Valls, PhD (+34 636 944 723, estudis@ctns.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of abdominal visceral fat (time frame: Change from 0 weeks (V1) to 12 weeks (V3)). 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 NCT02921217, 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 3 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.