Probiotic supplementation for abdominal obesity management

Randomized, Double-blind, Parallel, Placebo-controlled Study to Evaluate the Efficacy of Single Strain Probiotic, Delivered in a Chewing Gum, on the Reduction of Anthropometric Adiposity Biomarkers and the Improvement of Glucose Homeostasis in Abdominally Obese Individuals.

This study is testing whether a specific probiotic can help adults with belly fat lose inches around their waist and improve their overall health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University Rovira i Virgili (other)
• Locations: 1 site (Reus, Tarragona)
• Trial ID: NCT05882149 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of a single strain probiotic on abdominal obesity, focusing on its potential to reduce waist circumference and visceral fat. A total of 180 adult volunteers will participate, with half receiving the probiotic and the other half a placebo. Participants will undergo several visits, including blood tests and dietary assessments, to evaluate changes in body composition and metabolic markers. The study aims to determine if this probiotic can serve as a complementary strategy in managing cardiometabolic disease risk factors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of abdominal obesity, defined by specific waist circumference measurements.

Not a fit: Patients with a BMI of 40 kg/m2 or higher, or those with diagnosed type 1 or type 2 diabetes, may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a novel dietary intervention for individuals struggling with abdominal obesity and related health issues.

How similar studies have performed: Previous studies have shown promising results with similar probiotic interventions, suggesting potential efficacy in this area.

Eligibility criteria

Inclusion Criteria:

1. Male and female subjects ≥ 18 years old.
2. Established diagnosis of abdominal obesity: waist circumference (WC) ≥ 102 cm for men and ≥ 88 cm for women.
3. Voluntary, written, signed, informed consent to participate in the study.
4. Agreement to comply with the protocol and study restrictions.
5. Females of child-bearing potential require to provide a negative urine pregnancy test.

Exclusion Criteria:

1. WC \< 102 cm for men, \<88 cm for women, and \>150 cm.
2. BMI ≥ 40 kg/m2.
3. Diagnosed and pharmacologically-treated type 1 or type 2 diabetes (fasting blood glucose ≥ 7 mmol/l).
4. Subjects with serious autoimmune disease, cardiovascular disease, liver dysfunction/disease, kidney dysfunction/disease, dementia, pancreatic disease, history of cancer within past 5 years, anemia, or any other disease or condition which, in the Investigator's opinion, could interfere with the results of the study or the safety of the subject.
5. Immunosuppression or ongoing therapy causing immunosuppression.
6. Pharmacologically-treated (medication/supplements) dyslipidemia.
7. Subjects consuming antibiotics in the previous 1 month.
8. Subjects consuming probiotics and prebiotics at least 1 month prior to inclusion in the study or during the intervention period.
9. Use of drugs or supplements to manage body weight or body fat in the last 3 months.
10. Use of laxatives or fiber supplements in the past 4 weeks.
11. History of chronic active inflammatory disorders.
12. History of bariatric surgery.
13. History of any chronic gastrointestinal disease (e.g. IBD).
14. Regular use of systemic or inhaled corticosteroids, or systemic immunomodulatory drugs.
15. Significant change in tobacco, snuff, nicotine and e-cigarette use habits in the past 3 months or planned cessation of the use of these products during the trial.
16. Active or recent (last 3 months) participation in a weight loss program (diet and/or exercise).
17. Weight change (increase or loss) of 3 kg during the past 3 months.
18. Pregnant or planning pregnancy during the study or breastfeeding.
19. Participation in a clinical trial with an investigational product or drug within 60 days prior to screening.
20. Illicit drug users.
21. Alcohol abusers.
22. Known hypersensitivity to any ingredients in the active or placebo products.

Where this trial is running

Reus, Tarragona

• Universitat Rovira i Virgili — Reus, Tarragona, Spain (RECRUITING)

Study contacts

• Study coordinator: Anna Pedret Figuerola

Conditions: Abdominal Obesity, waist circumference, visceral fat, probiotic supplementation, chewing gum