Single Strain Probiotic

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

Interventions

DIETARY_SUPPLEMENT

Single strain probiotic

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).

DIETARY_SUPPLEMENT

Placebo

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).

Sponsors & Collaborators

• Biopolis S.L.

  collaborator INDUSTRY

• Chic-kles Gum, S.L.

  collaborator INDUSTRY

• Rosa Sola

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-22

Primary Completion

2025-02-01

Completion

2025-02-01

Countries

• Spain

Study Locations