UnknownPhase 3

Effect of a Probiotic on Visceral Fat Accumulation

Spain129 participantsStarted 2016-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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). * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of abdominal visceral fat

Timeframe: Change from 0 weeks (V1) to 12 weeks (V3)

Trial details

NCT IDNCT02921217

SponsorBiopolis S.L.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-05

Contact for this trial

Rosa Maria Valls, PhD

+34 636 944 723 estudis@ctns.cat

View on ClinicalTrials.gov More Obesity trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.