NCT05882149Completed

Single Strain Probiotic

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.

Source: ClinicalTrials.gov · Last updated 24 Mar 2026

Brief summary (registry, in English)

Probiotics have been recognized as functional foods with beneficial effects against obesity and cardiometabolic diseases, such as dyslipidemia, type 2 diabetes and the reduction of visceral fat mass, body weight and waist circumference. In previous studies, it was shown that capsule/powder probiotic or postbiotic supplementation containing a single strain probiotic, could reduce anthropometric parameters, including the visceral fat area, and contribute to type 2 diabetes management in subjects with abdominal obesity. Similar findings were found when this single strain probiotic was delivered through enriched seafood sticks. Results showed that enriched seafood sticks significantly reduced insulin concentrations and HOMA-IR, pulse pressure, waist circumference, body weight and triglycerides. These findings suggest that this specific single strain probiotic as a probiotic or postbiotic, could be a complementary strategy in the management of cardiometabolic disease risk factors. Probiotics have mostly been studied incorporated in dairy food matrix. Other food matrices, such as chewing gum, have scarcely been exploited by the food industry. Chewing gum as a novel vehicle for probiotics presents the ability to release active ingredients into the oral cavity with a steady and rapid action. Furthermore, it has a high acceptance amongst adults and children and present few side effects. No previous randomized controlled trials have examined the effect of a probiotic chewing gum on anthropometric adiposity biomarkers and glucose homeostasis in abdominally obese individuals. The main objective of the present study is to evaluate the efficacy of single strain probiotic in the reduction of waist circumference in abdominally obese individuals. The specific objectives: * To evaluate the efficacy of single strain probiotic in the improvement of other anthropometric biomarkers (waist-hip-ratio, body weight, BMI, total fat mass, visceral fat index, free fat mass, lean body mass, conicity index, visceral adipose tissue and subcutaneous fat). * To evaluate the efficacy of single strain probiotic in the management of glucose homeostasis. * To evaluate the efficacy of single strain probiotic in the management of serum lipid levels. * To evaluate the efficacy of single strain probiotic in the reduction of blood pressure and pulse pressure. * To asses Quality of life after single strain probiotic supplementation. * To identify changes in caloric intake and subjective satiety after single strain probiotic supplementation. * To identify changes in gastrointestinal health after single strain probiotic supplementation. * To identify changes in the oral microbiome after single strain probiotic supplementation. * To identify changes in the gastrointestinal microbiome after single strain probiotic supplementation.

Status (registry): Completed
Study type: Interventional
Enrollment: 124 (actual)
First submitted: 19 May 2023
Start date: Jun 2023
Primary completion date: Feb 2025
Lead sponsor: Rosa Sola
Diseases: Obesity
NCT number: NCT05882149

What you commit to

Study type: Interventional
Participants enrolled: 124
From Jun 2023 to the primary completion date, Feb 2025
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Immunosuppression or ongoing therapy causing immunosuppression.
Pharmacologically-treated (medication/supplements) dyslipidemia.
Subjects consuming antibiotics in the previous 1 month.
Subjects consuming probiotics and prebiotics at least 1 month prior to inclusion in the study or during the intervention period.
Use of drugs or supplements to manage body weight or body fat in the last 3 months.
Regular use of systemic or inhaled corticosteroids, or systemic immunomodulatory drugs.
Participation in a clinical trial with an investigational product or drug within 60 days prior to screening.
Illicit drug users.

Other illness

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.
History of chronic active inflammatory disorders.
History of bariatric surgery.
History of any chronic gastrointestinal disease (e.g. IBD).
Known hypersensitivity to any ingredients in the active or placebo products.

Lab values

Diagnosed and pharmacologically-treated type 1 or type 2 diabetes (fasting blood glucose ≥ 7 mmol/l).

Other

WC \< 102 cm for men, \<88 cm for women, and \>150 cm.
BMI ≥ 40 kg/m2.
Use of laxatives or fiber supplements in the past 4 weeks.
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.
Active or recent (last 3 months) participation in a weight loss program (diet and/or exercise).
Weight change (increase or loss) of 3 kg during the past 3 months.
Pregnant or planning pregnancy during the study or breastfeeding.
Alcohol abusers.

Who the study is looking for

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

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Universitat Rovira i Virgili Coordinator of this site? Confirm its status	Reus	Spain	Unknown status

Related publications

Ultrasound and MRI abdominal fat distribution and its associations with metabolic conditions in adults with abdominal obesity.Diabetes Obes Metab · 2026 · PMID 41403258

This page is information, not medical advice. Discuss any trial with your doctor.