Single Strain Probiotic — CHOICE  

Abdominal Obesity Clinical Trial

Official title: 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.

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

A total of 180 adult volunteers will be included in the intervention (90 in each arm of the intervention).

During the CHOICE study, there will be 6 visits in total. Of these visits, 3 will be face-to-face and 3 by telephone. The study visits will be the following: screening visit (V0, face-to-face): to check inclusion/exclusion criteria and, in case of satisfying the inclusion criteria; basal visit (V1, face-to- face); visits during the intervention (V2, V3 and V4 via telephone); final study visit (V5, face-to-face).

In visits V0, V1 and V5 volunteers must present themselves in fasting conditions of 8 hours to obtain blood samples. In visits V1 and V5 volunteers must bring saliva and faeces samples.

In order to measure the changes in visceral adipose tissue, up to five days prior to the visit V1 and approximately up to 3 days prior after the V5, volunteers must have a Nuclear Magnetic Resonance (NMR) for measuring visceral fat.

CHOICE Study

Visit 0 (V0, week -1): Recruitment and selection

• Information to the volunteer and signature of the informed consent.

• Revision of the inclusion/exclusion criteria.

• Elaboration of study clinical history.

• Vital signs (blood pressure/resting heart rate).

• Checking the concomitant medication.

• Anthropometry (waist circumference; hip; body weight and composition; height).

• Blood sample extraction.

• Delivery of the 3-day dietary record and the material for feaces and saliva sample recollection for V1.

• Schedule the first visit and instructions (fasting).

Visit 1 (V1, week 0): Basal visit

• NMR (±5 days V1).

• Revision of study clinical history.

• Vital signs (blood pressure/resting heart rate).

• Checking the concomitant medication.

• Anthropometry (waist circumference; hip; body weight and composition).

• Blood sample extraction.

• Abdominal fat Ultrasound.

• Checking the 3-day dietary record.

• Checking the Three Factor Eating Questionnaire (TFEQ).

• Checking the Bing Eating Scale (BES).

• Checking the satiety scale (VAS) and gastrointestinal health information.

• Collection of feaces samples.

• Collection of saliva samples.

• Delivery of the 3-day dietary record and the material for saliva and feaces sample for V5.

• Schedule the next telephone visit and also the final visit and instructions (fasting).

Visit 2 (V2, week 3): Follow-up during the intervention

• Checking the concomitant medication.

• Record adverse effects.

• Checking adherence to product consumption (treatment compliance)

• Checking the satiety scale.

• Checking the gastrointestinal health.

• Schedule the next visit and instructions.

Visit 3 (V3, week 6): Follow-up during the intervention

• Checking the concomitant medication.

• Record adverse effects.

• Checking adherence to product consumption (treatment compliance)

• Checking the satiety scale.

• Checking the gastrointestinal health.

• Schedule the next visit and instructions.

Visit 4 (V4, week 9): Follow-up during the intervention

• Checking the concomitant medication.

• Record adverse effects.

• Checking adherence to product consumption (treatment compliance)

• Checking the satiety scale.

• Checking the gastrointestinal health.

• Schedule the next visit and instructions (fasting).

Visit 5 (V2, week 12): Final visit

• NMR (±3 days before V5).

• Revision of study clinical history.

• Vital signs (blood pressure/resting heart rate).

• Anthropometry (waist circumference; hip; body weight and composition)

• Checking the concomitant medication.

• Blood sample extraction.

• Abdominal fat Ultrasound.

• Checking the 3-day dietary record.

• Checking the TFEQ.

• Checking the BES.

• Record of adverse effects.

• Checking the treatment compliance

• Checking the satiety scale. (VAS)

• Collection of feaces samples.

• Collection of saliva samples. ;

Related Conditions & MeSH terms

• Abdominal Obesity
• Obesity, Abdominal

• NCT number: NCT05882149
• Study type: Interventional
• Source: University Rovira i Virgili
• Contact: Anna Pedret Figuerola
• Phone: 0034 977759375
• Email: anna.pedret@urv.cat
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2023
• Completion date: September 2024