Single Strain Probiotic

NCT05882149 | Completed

• 1 other identifier: 074/2023
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Obesity

Keywords

waist circumference; visceral fat; probiotic supplementation; chewing gum

Outcome Measures

Primary Outcomes (2)

• Change in waist circumference

  Difference in waist circumference (cm) measured by an MRI transverse body scan in one axial slice 5 cm over L5 from week 0 to week 12

  From week 0 to Week 12

• Changes in intra-abdominal area

  Differences in intra-abdominal area (cm2) measured by MRI (transverse body scan in one axial slice 5cm over L5) from week 0 to week 12

  Week 0 to week 12

Secondary Outcomes (37)

• Change in hip circumference

  From week 0 to Week 12

• Change in waist-hip-ratio

  From week 0 to Week 12

• Change in Body weight

  From week 0 to Week 12

• Change in Body mass index

  From week 0 to Week 12

• Change in Total fat mass

  From week 0 to Week 12

Study Arms (2)

Probiotic

EXPERIMENTAL

Sugar-free chewing gum with single strain probiotic and zinc. A daily dose of 2 chewing gums containing 1x10\^10 Colony Forming Unit (CFU) for 12 weeks.

Dietary Supplement: Single strain probiotic

Placebo

PLACEBO COMPARATOR

Sugar-free chewing gum for 12 weeks.

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Sugar-free chewing gum. The dosage will be 2 chewing a day, served at the same time and chewed for 6 minutes outside meals (for example 2h after breakfast or lunch).

Placebo

Single strain probiotic DIETARY_SUPPLEMENT

Sugar-free chewing gum with single strain probiotic and zinc. The dosage will be 2 chewing a day, served at the same time and chewed for 6 minutes outside meals (for example 2h after breakfast or lunch).

Probiotic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• WC \< 102 cm for men, \<88 cm for women, and \>150 cm.
• BMI ≥ 40 kg/m2.
• Diagnosed and pharmacologically-treated type 1 or type 2 diabetes (fasting blood glucose ≥ 7 mmol/l).
• 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.
• Immunosuppression or ongoing therapy causing immunosuppression.
• Pharmacologically-treated (medication/supplements) dyslipidemia.
• Subjects consuming antibiotics in the previous 1 month.
• Use of drugs or supplements to manage body weight or body fat in the last 3 months.
• Use of laxatives or fiber supplements in the past 4 weeks.
• History of chronic active inflammatory disorders.
• History of bariatric surgery.
• History of any chronic gastrointestinal disease (e.g. IBD).
• Regular use of systemic or inhaled corticosteroids, or systemic immunomodulatory drugs.
• 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).

Sponsors & Collaborators

• Biopolis S.L.: collaborator
• Chic-kles Gum, S.L.: collaborator
• Rosa Sola: lead

Study Sites (1)

Universitat Rovira i Virgili

Reus, Tarragona, 43201, Spain

Location

Related Publications (1)

• Jimenez-Ten Hoevel C, Besora-Moreno M, Queral J, Llaurado E, Valls RM, Sola R, Pedret A. Ultrasound and MRI abdominal fat distribution and its associations with metabolic conditions in adults with abdominal obesity. Diabetes Obes Metab. 2026 Mar;28(3):2061-2074. doi: 10.1111/dom.70390. Epub 2025 Dec 17.

  PMID: 41403258 DERIVED

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor, full professor

Model Details: Randomized, double-blind, parallel, placebo-controlled intervention study. The total duration of the intervention will be 12 weeks. The study will have two arms of intervention. The intervention product will be: sugar-free chewing gum with single strain probiotic and zinc. The Placebo product will be: sugar-free chewing gum. The placebo products and the intervention products will present the same format and appearance, in order to ensure the double-blind intervention

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: June 22, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)